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.
Related Link: 5 Biotech Stocks To Watch During The Week Of June 13
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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.
All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.
Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.
Rate collection and criteria: Click here for more information on rate collection and criteria.