Novartis drug Ilaris® approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis

Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris(canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection. SJIA is a rare and disabling form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old and can continue into adulthood

This approval was based on two Phase III trials in SJIA patients, aged 2–19, showing significant improvement in the majority of Ilaris-treated patients. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15. In the open-label part of Study 2, 92 of 128 patients attempted corticosteroid tapering. Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group as compared to those in the placebo group 

Source: Novartis

New drug approved by US FDA for the treatment of COPD

The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States.

Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.

“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Those treated showed improved lung function and reduced exacerbations compared to placebo.

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.

The FDA approved Breo Ellipta with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug. Breo Ellipta should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.

Breo Ellipta may cause serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects reported by patients using Breo Ellipta included inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache, and oral candidiasis (thrush).

Breo Ellipta was developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance.

Source: FDA

FDA approves Adcetris to treat two types of lymphoma

The U.S. Food and Drug Administration has approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL.

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FDA approves Rituxan to treat two rare disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclosphosphamide.

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

FDA Approves Victoza (liraglutide) for Type 2 Diabetes

he U.S. Food and Drug Administration approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.

In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.

The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.

Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product.

In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.

In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive.

It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2.

Ranbaxy Launches A New Chemical Entity (NCE), Lulifin (Luliconazole) In India

Ranbaxy Laboratories Limited (Ranbaxy) has launched a New Chemical Entity (NCE), Lulifin (Luliconazole), in the Indian Dermatology market. This follows a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI) allowing Ranbaxy, exclusive marketing rights, for India. The introduction of this NCE, significantly strengthens Ranbaxy’s presence in the Dermatological segment.

Commenting on the development, Mr. Sanjeev Dani, Sr. Vice President & Regional Director – Asia, CIS & Africa, Ranbaxy, said, “It is well recognized that in the post patent era, licensing would be the key strategy to bring New Chemical Entities to India. Dermatology is one of the top priority therapeutic areas for us and we are pleased to introduce Lulifin in the Indian market. We would be manufacturing the product in India under licence from SPI, Japan.”

Luliconazole was discovered by Nihon Nohyaku Co. Ltd. (Nihon Nohyaku) and was approved and launched in Japan in 2005. Based on SPI’s licensing know-how and strong network abroad, SPI in-licensed the rights for Luliconazole in certain territories from Nihon Nohyaku, to expand its reach in overseas markets. In India, SPI has entered into a licensing agreement with Ranbaxy to market the product exclusively.

Lulifin is a topical imidazole and is indicated for Cutaneous mycoses caused by Tinea pedis, Tinea corporis, Tinea cruris. Currently, topical imidazoles and allylamines are used for the treatment of Cutaneous mycoses with disadvantages like long duration of therapy, which leads to poor compliance and a high relapse rate. Clinical trials conducted by Nihon Nohyaku with Pola Chemical Industries, Inc. (currently Pola Pharma Inc. Tokyo), in Japan and by Ranbaxy, in India, confirm the at par efficacy with other topical imidazoles but with the added advantage of shorter therapy duration and once a day application. This greatly improves patient compliance with significantly better outcomes.

Ranbaxy already has a strong presence in the Dermatology market with products such as Zole-F, Minoz, Suncros, Fucidin and Teczine, among others.

SPI is a 100% daughter subsidiary company of Sumitomo Corporation (SC) and is an integrated service company specializing in the area of pharmaceutical research and development. SPI has a good track record in activities such as, exclusive agent of ATCC (the world’s largest gene/cell bank for research) of the USA, support of discovery research through distribution/sales of compound libraries for HTS (High Throughput Screening – high-speed technology for early drug candidate compounds selection in discovery research), supply of starting materials, intermediates and bulk drug substances for pharmaceuticals, and intermediation/consultation services in license/co-research arrangements of promising drugs/diagnostics/technologies originating from domestic and foreign bio-ventures, pharmaceutical companies, universities and institutes.

FDA Approves New Treatment for Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).

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Record Number of Medicines In Development to Treat Diseases Affecting Women

America’s pharmaceutical research and biotechnology companies are working on nearly 1,000 life–changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the U.S. Food and Drug Administration or are in human clinical trials.

In the U.S., diseases that disproportionately affect women include diabetes, which has reached epidemic proportions and affects 11 million women nationwide. Autoimmune diseases strike women three times more and anxiety and depression two times more women than men. The number one killer of American women is heart disease.

The report lists 969 new medicines in development. They include 112 new treatments for breast cancer, 86 new treatments for obstetric/gynecologic conditions, 76 for asthma, 114 for autoimmune diseases, 155 for diabetes, 131 for arthritis, and 80 for Alzheimer’s disease.

One medicine in the report is a potential cutting–edge treatment that attacks the cause of Alzheimer’s disease rather than merely treating its symptoms. Currently, treatment options for Alzheimer’s disease are limited. This groundbreaking medicine holds the potential to slow the progression of the disease and could vastly improve quality of life for Alzheimer’s patients. Women account for 70 percent of Alzheimer’s deaths.

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FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes

The U.S. Food and Drug Administration recently approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

"Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease."

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Advinus Therapeutics files its First Investigational New Drug Application

Advinus Therepeutics announced that it has filed its first IND with the DCGI last week for a type 2 diabetes molecule and expects to commence phase 1 clinical trials shortly after approval.

Dr. Rashmi Barbhaiya, the CEO and Managing Director of the company stated, "Our drug discovery operations have now been expanded to almost 3 folds of what they were. The new facility will give us a lot of room for growth of internal programmes and innovative models for future partnerships. I am very proud that in less than 3 years we have been able to file our first IND for approval of clinical trials which is a combined effort of both our Pune and Bangalore operations."

Dr. Kasim Mookhtiar, Chief Scientific Officer of the company added, that "the filing of Advinus' first IND marks the beginning of the company's delivery of a pipeline of innovative products that addresses large unmet medical needs."