USFDA approves drug for Alopecia, includes safety warning too

Olumiant is a once-daily pill that will be sold in three different doses

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USFDA Approval
USFDA Approval

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Last Updated on October 10, 2024 by The Health Master

The U.S. Food and Drug Administration (USFDA) cleared the first systemic therapy for severe alopecia areata, an autoimmune condition that causes hair loss, while warning patients of potentially deadly side effects.

Eli Lilly and Incyte developed the drug, known as Olumiant, which is already used to treat rheumatoid arthritis and certain patients with C-19.

It’s part of a class of medicines known as JAK inhibitors that have proven effective against a range of inflammatory diseases but have also been linked to conditions including heart attacks, strokes and cancer. 

Olumiant is a once-daily pill that will be sold in three different doses, Lilly said Monday.

The list price for a 30-day supply of the middle dose, 2 mg, will cost $2,497.20, but the actual cost to patients will depend on their insurance.

Safety warning

The caution in dosing goes along with a black box warning required by the FDA. Patients need to be advised of the potential for “serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis,” the agency said in announcing the approval of the medicine. 

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