Drugs

Lilly’s Olumiant Approved for Alopecia

FDA has approved an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, an autoimmune disorder that presents with baldness patches. The Janus kinase (JAK) inhibitor works by blocking the “activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation,” an FDA release says.

Approval was based on data from two placebo-controlled trials (Trial AA-1 and Trial AA-2) in patients who had at least 50% scalp hair loss for more than six months. The efficacy measurement in both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36, according to FDA.

“In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo,” the agency says. “In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo.”

Olumiant was first approved in 2018 for treating moderately to severely active rheumatoid arthritis and is also approved for the treatment of certain hospitalized adults with Covid-19. The therapy carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

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