Drugs

Lilly/Incyte Plan sNDA for Baricitinib in Alopecia

Eli Lilly and and Incyte say they plan to file in the second half of this year a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a second Phase 3 trial (BRAVE-AA1). They say the data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, announced earlier this year. “In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo,” they say.

Baricitinib is a once-daily, oral JAK inhibitor approved in the U.S. under the trade name Olumiant as a treatment for adults with moderate to severe rheumatoid arthritis. The proposed submission may face greater scrutiny due ongoing FDA safety concerns with JAK inhibitors (see earlier story). FDA recently extended the review period for a supplemental NDA for Olumiant (baricitinib) for treating adults with moderate to severe atopic dermatitis.

The drug class concerns arose from an FDA-required safety study when Pfizer’s Xeljanz (tofacitinib) was approved in 2012 for rheumatoid arthritis. In 2/2019 and 7/2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice daily dosage, and as a result, approved a Boxed Warning. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both the 5mg and 10mg doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.

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