Lilly-Incyte Snag FDA Nod For Patchy Hair Loss Treatment — Smaller Rival's Stock Shoots Up In Sympathy

Alopecia areata, an autoimmune disorder that causes patchy hair loss, now has a new treatment that has been approved by the Food and Drug Administration.

Eli Lilly & Company LLY and Incyte Corporation INCY announced that the FDA approved Olumiant, a once-daily pill, as the first systemic treatment for adults with severe alopecia areata. It is available in tablet formulation, in 4-mg, 2-mg and 1-mg strengths.

Systemic treatments are those which travel through the bloodstream and reach all cells of the body.

Olumiant belongs to a class of drugs called JAK inhibitors that inhibit the activity of one more of the Janus Kinase family of enzymes that interfere with the JAK-STAT signaling pathway. These have applications in cancer and inflammatory diseases.

The recommended dose is 2-mg/day, with an increase to 4-mg/day if the treatment response is inadequate. Patients with nearly-complete or complete hair loss, with or without eyelash or eyebrow hair loss, can consider the 4-mg/day dose, the companies said.

Lilly and Incyte cautioned that Olumiant should not be used in combination with JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

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Why It's Important: Olumiant has turned in encouraging efficacy results in Phase 2/3 studies. One in five adults taking a 2-mg/day dose and one in three taking a 4-mg/dose achieved significant hair regrowth, resulting in 80% or more scalp coverage, and improvements in eyebrow and eyelash, the companies said, citing Brett King lead investigator of the Olumiant clinical studies.

The FDA also made it mandatory to include a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

Pfizer, Inc. PFE and Concert Pharmaceuticals, Inc. CNCE have rival systemic treatment candidates for alopecia in their respective pipelines. Concert Pharma reacted positively to the Lilly news, seemingly as investors see the boxed label for Lilly's treatment as a positive for the former.

The disorder became widely known after the Will Smith 'slapgate' scandal at the 2022 Oscars. The U.S. rapper and actor smacked comedian Chris Rock for making fun of his wife Jada Pinkett's shaved head. She had said in the past she suffered from alopecia on account of which she shaved her had.

Price Action: Incyte shares traded 0.74% lower at $67.25 in the premarket session, according to Benzinga Pro data. Concert Pharma rallied 13.25% to $4.70.