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Pfizer (PFE) Eczema Drug Cibinqo Gets FDA Nod for Adolescents
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Pfizer(PFE - Free Report) announced that the FDA has granted approval to its oral, once-daily, JAK1 inhibitor, Cibinqo (abrocitinib), for the treatment of refractory moderate-to-severe atopic dermatitis (AD) — also called eczema — in adolescents. The approval is for adolescent patients, aged 12 to less than 18 years of age, who did not respond adequately to treatment with other systemic drug products, including biologics, or when the use of other treatments is not recommended.
Cibinqo was approved for treating eczema in adults 18 years and older in January 2022. With the label expansion, adolescents with AD will get a new systemic oral option for their disease.
In the past year, Pfizer’s stock has declined 11.9% against an increase of 13% for the industry.
Image Source: Zacks Investment Research
The FDA approval for Cibinqo for adolescents was based on data from the phase III study, JADE TEEN, which evaluated two doses (100 mg and 200 mg) of Cibinqo in adolescent patients (12 to <18 years of age) with moderate-to-severe AD. JADE TEEN is one of the five studies in the JADE clinical development program on Cibinqo. Across the five studies, treatment with Cibinqo led to significant improvements in skin clearance, the extent of disease and severity as well as rapid improvement in itch after two weeks, in certain patients with AD, including adolescent patients.
Some other JAK inhibitor medicines are Pfizer’s drug, Xeljanz, AbbVie’s (ABBV - Free Report) Rinvoq and Eli Lilly’s (LLY - Free Report) Olumiant.
Among these, only AbbVie’s Rinvoq is approved to treat moderate-to-severe AD in adults and adolescents. In fact, Rinvoq is approved for treating five indications, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis and ulcerative colitis. The medicine contributed $2.5 billion to AbbVie’s total revenues in 2022, rising 52.8% year over year.
Eli Lilly’s Olumiant and Pfizer’s Xeljanz are not approved for treating AD. While Olumiant is approved for rheumatoid arthritis and COVID-19 in certain patients. Pfizer’s Xeljanz is approved for RA, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in certain patients.
Zacks Rank and Stocks to Consider
Pfizer currently has a Zacks Rank #5 (Strong Sell).
A better-ranked large drugmaker is Sanofi (SNY - Free Report) , which has a Zacks Rank of 2 (Buy).
Estimates for Sanofi’s 2023 earnings per share have increased from $4.41 per share to $4.46 per share in the past 30 days, while the same for 2024 has gone up from $4.79 per share to $4.90 per share in the same time frame. Sanofi’s stock has declined 9% in the past year.
Sanofi beat earnings expectations in three of the trailing four quarters while missing in one. The company delivered a four-quarter earnings surprise of 7.68%, on average.
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Pfizer (PFE) Eczema Drug Cibinqo Gets FDA Nod for Adolescents
Pfizer (PFE - Free Report) announced that the FDA has granted approval to its oral, once-daily, JAK1 inhibitor, Cibinqo (abrocitinib), for the treatment of refractory moderate-to-severe atopic dermatitis (AD) — also called eczema — in adolescents. The approval is for adolescent patients, aged 12 to less than 18 years of age, who did not respond adequately to treatment with other systemic drug products, including biologics, or when the use of other treatments is not recommended.
Cibinqo was approved for treating eczema in adults 18 years and older in January 2022. With the label expansion, adolescents with AD will get a new systemic oral option for their disease.
In the past year, Pfizer’s stock has declined 11.9% against an increase of 13% for the industry.
Image Source: Zacks Investment Research
The FDA approval for Cibinqo for adolescents was based on data from the phase III study, JADE TEEN, which evaluated two doses (100 mg and 200 mg) of Cibinqo in adolescent patients (12 to <18 years of age) with moderate-to-severe AD. JADE TEEN is one of the five studies in the JADE clinical development program on Cibinqo. Across the five studies, treatment with Cibinqo led to significant improvements in skin clearance, the extent of disease and severity as well as rapid improvement in itch after two weeks, in certain patients with AD, including adolescent patients.
Some other JAK inhibitor medicines are Pfizer’s drug, Xeljanz, AbbVie’s (ABBV - Free Report) Rinvoq and Eli Lilly’s (LLY - Free Report) Olumiant.
Among these, only AbbVie’s Rinvoq is approved to treat moderate-to-severe AD in adults and adolescents. In fact, Rinvoq is approved for treating five indications, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis and ulcerative colitis. The medicine contributed $2.5 billion to AbbVie’s total revenues in 2022, rising 52.8% year over year.
Eli Lilly’s Olumiant and Pfizer’s Xeljanz are not approved for treating AD. While Olumiant is approved for rheumatoid arthritis and COVID-19 in certain patients. Pfizer’s Xeljanz is approved for RA, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in certain patients.
Zacks Rank and Stocks to Consider
Pfizer currently has a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked large drugmaker is Sanofi (SNY - Free Report) , which has a Zacks Rank of 2 (Buy).
Estimates for Sanofi’s 2023 earnings per share have increased from $4.41 per share to $4.46 per share in the past 30 days, while the same for 2024 has gone up from $4.79 per share to $4.90 per share in the same time frame. Sanofi’s stock has declined 9% in the past year.
Sanofi beat earnings expectations in three of the trailing four quarters while missing in one. The company delivered a four-quarter earnings surprise of 7.68%, on average.