Pfizer's (PFE) Litfulo Receives FDA Nod for Alopecia Areata
Pfizer PFE announced that the FDA approved Litfulo (ritlecitinib) for treating people with severe alopecia areata.
The regulatory agency approved the drug as an oral treatment for those aged 12 years and older.
Alopecia areata is a medical condition, characterized by the partial or complete loss of hair on the scalp, face, or body, due to an autoimmune response.
The approval was based on the compelling data from the ALLEGRO phase IIb/III study, which demonstrated the efficacy and safety of Litfulo. In the study, 23% of patients who received a 50-mg daily dose of the drug achieved 80% or more scalp hair coverage after six months compared with only 1.6% in the placebo group.
Shares of Pfizer have lost 25.2% year to date against the industry’s 2.0% growth.
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Litfulo is a kinase inhibitor that focuses on two distinct enzymes, namely Janus kinase 3 and the tyrosine kinase. Through the precise inhibition, Litfulo demonstrates its ability to address the root cause of the condition and potentially restore hair growth.
Following the approval, Litfulo becomes the first and only FDA-approved treatment for adolescents with hair loss caused by an autoimmune disease. Prior to this, there was no approved treatment available, specifically for adolescents. Adults had limited options for treating alopecia areata. The approval will boost Pfizer's diversified portfolio.
Ritlecitinib is under review in Japan and Europe for treating alopecia areata. In September 2022, PFE submitted a regulatory filing in the European Union, seeking approval for ritlecitinib, which is currently under review. The decision pertaining to the application is expected in the third quarter of 2023.
Litfulo is also being evaluated for vitiligo, Crohn’s disease and ulcerative colitis.
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Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Novartis NVS, Akero Therapeutics AKRO and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.49 per share to a loss of $2.05 for 2023 in the past 90 days. Shares of the company have rallied 22.9% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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