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Pfizer (PFE) Alopecia Drug Filings Get Accepted by FDA, EMA
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Pfizer (PFE - Free Report) announced that the FDA has accepted its new drug application (NDA), seeking approval of ritlecitinib, its investigational JAK3 inhibitor for severe alopecia areata (“AA”).
The FDA granted a standard review to the NDA with a decision expected in the second quarter of 2023. The European Medicines Agency (EMA) also accepted ritlecitinib’s marketing authorization application (MAA). The EMA’s decision is expected in the fourth quarter of 2023.
The regulatory applications were based on data from the phase IIb/III ALLEGRO study on ritlecitinib for severe alopecia areata, which showed that treatment with ritlecitinib led to significant scalp hair regrowth versus placebo. The data showed that patients treated with ritlecitinib 30 mg or 50 mg once-daily experienced 80% or more scalp hair coverage after six months of treatment versus placebo. The regulatory applications also included data from an ongoing phase III ALLEGRO-LT open-label, long-term study.
Pfizer’s stock is down 19% this year so far compared with a decrease of 1.7% for the industry.
Image Source: Zacks Investment Research
Alopecia areata, commonly referred to as just alopecia, is an autoimmune disease, which results in non-scarring hair loss, mainly on the scalp. It can also cause hair loss in eyebrows, eyelashes, facial hair and other areas of the body. The disorder affects approximately 6.8 million people in the United States. Until recently, there was no FDA-approved drug available to treat this condition, which can lead to high levels of depression and anxiety in patients.
In June, Eli Lilly (LLY - Free Report) and partner Incyte’s (INCY - Free Report) oral JAK inhibitor, Olumiant (baricitinib) was approved by the FDA as a 4-mg, 2-mg and 1-mg once-daily tablet for treating adults with severe AA. With the approval, Olumiant became the first FDA-approved systemic treatment for AA. Systemic treatments are treatments that target the entire body and not any specific area. Data from clinical studies, which supported the drug’s approval showed that 17-22% of patients taking Lilly/Incyte’s Olumiant 2-mg/day and 32-35% of patients taking Olumiant 4-mg/day achieved 80% or more scalp hair coverage
Besides AA, Lilly/Incyte’s Olumiant is approved to treat rheumatoid arthritis and COVID-19 in certain hospitalized adults requiring various degrees of oxygen support. Olumiant is also approved in Europe and Japan for atopic dermatitis, while it is under review in the United States for the same indication.
A better-ranked stock in the same sector is Agenus (AGEN - Free Report) which has a Zacks Rank #1 at present.
Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 16.4% in the year-to-date period.
Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.
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Pfizer (PFE) Alopecia Drug Filings Get Accepted by FDA, EMA
Pfizer (PFE - Free Report) announced that the FDA has accepted its new drug application (NDA), seeking approval of ritlecitinib, its investigational JAK3 inhibitor for severe alopecia areata (“AA”).
The FDA granted a standard review to the NDA with a decision expected in the second quarter of 2023. The European Medicines Agency (EMA) also accepted ritlecitinib’s marketing authorization application (MAA). The EMA’s decision is expected in the fourth quarter of 2023.
The regulatory applications were based on data from the phase IIb/III ALLEGRO study on ritlecitinib for severe alopecia areata, which showed that treatment with ritlecitinib led to significant scalp hair regrowth versus placebo. The data showed that patients treated with ritlecitinib 30 mg or 50 mg once-daily experienced 80% or more scalp hair coverage after six months of treatment versus placebo. The regulatory applications also included data from an ongoing phase III ALLEGRO-LT open-label, long-term study.
Pfizer’s stock is down 19% this year so far compared with a decrease of 1.7% for the industry.
Image Source: Zacks Investment Research
Alopecia areata, commonly referred to as just alopecia, is an autoimmune disease, which results in non-scarring hair loss, mainly on the scalp. It can also cause hair loss in eyebrows, eyelashes, facial hair and other areas of the body. The disorder affects approximately 6.8 million people in the United States. Until recently, there was no FDA-approved drug available to treat this condition, which can lead to high levels of depression and anxiety in patients.
In June, Eli Lilly (LLY - Free Report) and partner Incyte’s (INCY - Free Report) oral JAK inhibitor, Olumiant (baricitinib) was approved by the FDA as a 4-mg, 2-mg and 1-mg once-daily tablet for treating adults with severe AA. With the approval, Olumiant became the first FDA-approved systemic treatment for AA. Systemic treatments are treatments that target the entire body and not any specific area. Data from clinical studies, which supported the drug’s approval showed that 17-22% of patients taking Lilly/Incyte’s Olumiant 2-mg/day and 32-35% of patients taking Olumiant 4-mg/day achieved 80% or more scalp hair coverage
Besides AA, Lilly/Incyte’s Olumiant is approved to treat rheumatoid arthritis and COVID-19 in certain hospitalized adults requiring various degrees of oxygen support. Olumiant is also approved in Europe and Japan for atopic dermatitis, while it is under review in the United States for the same indication.
Zacks Rank & Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked stock in the same sector is Agenus (AGEN - Free Report) which has a Zacks Rank #1 at present.
Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 16.4% in the year-to-date period.
Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.