Drugs

Galapagos, Gilead Launch Phase 3 Program for Arthritis Drug

Galapagos and Gilead have begun a Phase 3 clinical trial program called FINCH that will investigate the efficacy and safety of 100 mg and 200 mg filgotinib once daily in rheumatoid arthritis patients. The program includes the following three studies:

FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled study in combination with methotrexate (MTX) in 1,650 patients who have had inadequate response to MTX. The primary endpoint is American College of Rheumatology 20% (ACR20) response rate at week 12, which signifies a 20% or greater improvement in the number of swollen and tender joints as well as a 20% or greater improvement in three out of five other disease-activity measures. The study will also include radiographic assessment at weeks 24 and 52.
FINCH 2 is a 24-week, randomized, placebo-controlled study in an expected 423 patients who are on conventional disease-modifying anti-rheumatic drugs, and have had an inadequate response to biological treatment. The primary endpoint is ACR20 at week 12.
FINCH 3 is a 52-week, randomized study in an expected 1,200 MTX-naïve patients to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint is ACR20 at week 24. Radiographic progression will also be assessed.

The FINCH program in rheumatoid arthritis will be conducted in the U.S. and Europe to start, with other regions to follow.

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