FDA Approves KRYSTEXXA® (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy

Horizon Therapeutics (Nasdaq: HZNP) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.

The expanded labeling for KRYSTEXXA with methotrexate is based on the results from the MIRROR randomized controlled trial in which adults living with uncontrolled gout were randomized to receive methotrexate (15 mg/week) or placebo for four weeks, and then treatment with KRYSTEXXA with methotrexate or KRYSTEXXA with placebo for 52 weeks. The primary endpoint was defined as the proportion of serum uric acid (sUA) responders during Month 6 (defined as sUA less than 6 mg/dL at least 80% of the time).

AIDS Healthcare Foundation (AHF) urges the World Health Organization to declare Monkeypox as a Pandemic

With more than 7,600 cases throughout 58 countries globally, AIDS Healthcare Foundation (AHF) urges the World Health Organization not to repeat the past mistake of delaying declarations for COVID-19 and immediately declare the monkeypox outbreak a public health emergency of international concern (PHEIC).

A PHEIC declaration for monkeypox would also add urgency to produce and widely distribute sufficient quantities of vaccines and tests. The U.S. Food and Drug Administration has already approved JYNNEOS, a smallpox vaccine, for use to prevent monkeypox infection. The European Medicines Agency is considering the same for Imvanex, the same drug marketed under a different name, according to Health Policy Watch.

AHF issued a previous statement calling on the WHO to declare the monkeypox outbreak a public health emergency of international concern after the global health agency failed to do so at its meeting on June 25.

ADC Therapeutics Announces Exclusive License Agreement with Sobi to Develop and Commercialize ZYNLONTA (loncastuximab tesirine-lpyl) in Europe and Select International Territories

ADC Therapeutics SA (NYSE: ADCT) have announced that they have entered into an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi®) for the development and commercialization of ZYNLONTA® for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan. 

The Marketing Authorization Application (MAA) for ZYNLONTA was validated by the European Medicines Agency (EMA) at the end of October 2021, and orphan drug designation was granted for ZYNLONTA for the treatment of diffuse large B-cell lymphoma (DLBCL) in Europe. ADC Therapeutics and Sobi intend to make ZYNLONTA available following a regulatory decision that is expected by the first quarter of 2023.

Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $55 million, and is eligible to receive $50 million upon regulatory approval of ZYNLONTA in third-line DLBCL by the European Commission and up to approximately $330 million in additional regulatory and sales milestones. 

ADC Therapeutics will also receive a percentage of royalties ranging from the mid-teens to the mid-twenties based on net sales of ZYNLONTA in Sobi’s territories. Sobi will share a portion of select global ZYNLONTA clinical trial costs.