- Incyte on Tuesday won Food and Drug Administration approval for Opzelura, a topical cream formulation of its top-selling drug that can be used to treat the skin disease eczema.
- The FDA cleared Opzelura for patients 12 and older with mild-to-moderate forms of the disease, also known as atopic dermatitis. The approval covers non-immunocompromised patients who aren't candidates for other topical medications or who haven't benefited enough from existing therapies.
- Like other medicines in its class, Incyte's new cream will carry warnings about potentially dangerous side effects including severe infection, heart attack and blood clots. Opzelura has the same active ingredient, ruxolitinib, as the company's blockbuster Jakafi drug and is part of a class known as JAK inhibitors, the rest of which are taken orally.
While the approval is good news for Incyte and its effort to expand, the boxed warning for the cream may give some potential patients and prescribing doctors pause, according to Stephen Willey, an analyst at Stifel. That may prove especially true for Incyte's next push into the pediatric market, Willey wrote in a note to clients.
Opzelura and Jakafi are part of a class of drugs that work to block Janus kinases, or JAKs, a group of proteins that play a role in the body's immune system. The FDA has paid increased attention to the class amid recent safety concerns, and placed new restrictions on three drugs — sold by Pfizer, Eli Lilly and AbbVie — several weeks ago.
Jakafi is currently approved to treat certain patients with blood disorders and graft-versus-host disease. It's by far Incyte's biggest product, accounting for $529 million of the company's $696 million in product and royalty revenue in the second quarter.
Jakafi's success has put pressure on Incyte to deliver more new products. So far, that's been an up-and-down journey for the Delaware-based biotech. Last year, the company won FDA approval of a lymphoma treatment called Monjuvi along with partner MorphoSys. But earlier this year, an FDA advisory panel voted against the company's experimental cancer drug retifanlimab, which was later rejected by the agency.
Opzelura is the first JAK inhibitor to be sold as a topical formulation, Incyte said. The FDA's approval was based on a clinical trial called TRuE-AD, which found the cream could significantly reduce itching and result in clearer skin.