Drugs

Gilead Abandons Jyseleca for RA in the U.S.

Gilead Sciences and Galapagos are scrapping the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis (RA) after a recent meeting with FDA to discuss an 8/18 NDA complete response letter over testicular toxicity concerns. FDA told the companies that “substantial additional clinical studies” would be required to support a 200mg dose. Filgotinib is approved and marketed in Europe and Japan for treating adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs.

During its NDA review, the agency requested data from the MANTA and MANTA RAy studies, which are intended to assess whether filgotinib has an impact on sperm parameters. “Week 26 data from the MANTA and MANTA-RAy studies, including primary and key secondary endpoints, will be available by mid-2021 and the parties expect to submit the data to regulatory authorities shortly thereafter,” the companies say. “In order to complete their review of filgotinib in RA or other future indications, the FDA has requested up to Week 52 follow-up data for patients who show >50% decrease in semen parameters by Week 26 and do not recover in the ongoing MANTA and MANTA-RAy studies.”

Gilead and Galapagos say they will continue to investigate the potential for filgotinib to support patients living with inflammatory bowel disease.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome