FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

Dive Brief:

• The Food and Drug Administration on Monday 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 COVID-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.

Dive Insight:

Lilly and Incyte edged out Pfizer and Concert Pharmaceuticals in the race to bring to market a treatment for alopecia areata, a disease that causes patches of hair loss and affects hundreds of thousands of Americans, including actress Jada Pinkett Smith.

Researchers studied the medicine in patients who had lost at least half of the hair on their scalps. In two Phase 3 trials, they found that about a third of patients who received a 4 mg dose of Olumiant achieved at least 80% scalp coverage after 36 weeks of treatment. About a fifth of patients on the 2 mg dose saw similar results.

Doctors should usually start patients with a 2 mg tablet and consider a higher dose if it’s not proving effective enough, Lilly said. Patients with almost complete hair loss or issues like eyelash or eyebrow loss may be candidates to begin on the higher dose, the company said.

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. 

That warning reflects the increased scrutiny JAK inhibitors have drawn from drug regulators in recent years. Multiple studies have unearthed links between the medicines and heart problems, infections and cancers, prompting the FDA to put warnings on their prescribing information and limit their use. The European Medicines Agency, too, has begun a safety review. 

That profile, combined with the drug’s high cost, has caused some experts to express concern about using JAK inhibitors for alopecia areata and could complicate its launch. Lilly, however, is hoping that the need for Olumiant will outweigh the potential side effects. More than 300,000 people in the U.S. suffer from severe alopecia, according to the FDA. Typical treatments include off-label use of immunosuppressive drugs, or hair-regrowth methods like platelet-rich-plasma therapy or minoxidil. 

Olumiant is one of a slew of products for immunologic disorders in Lilly’s pipeline. The company also has treatments for plaque psoriasis, ulcerative colitis and Crohn’s disease, among others. About 12 million Americans have auto-immune disorders and there is a great unmet need for effective therapies, company executives said in a recent presentation. 

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