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Pharma Stock Roundup: EU Nod to PFE's Litfulo, FDA Priority Tag to MRK Applications
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This week, the European Commission granted marketing approval to Pfizer’s (PFE - Free Report) Litfulo (ritlecitinib), an oral capsule to treat severe alopecia areata. The FDA granted priority review designation to Merck’s regulatory applications seeking approvals for expanded use of Merck’s (MRK - Free Report) Welireg and Keytruda. AstraZeneca’s (AZN - Free Report) Enhertu was recommended for approval in the EU by the Committee for Medicinal Products for Human Use (CHMP) for treating HER2-mutant non-small cell lung cancer (NSCLC).
Recap of the Week’s Most Important Stories
Pfizer’s Alopecia Areata Drug Gets Approval in Europe: The European Commission granted marketing authorization to Pfizer’s Litfulo (ritlecitinib), a once-daily oral capsule to treat adults and adolescents, aged 12 years and older, with severe alopecia areata. The approval was based on data from Pfizer’s ALLEGRO program on the candidate, which included the phase IIb/III ALLEGRO study. Lilly’s Olumiant (baricitinib) is also a once-daily pill approved in Europe for treating adult patients with severe alopecia areata. With the approval, Litfulo, a JAK inhibitor, became the first medicine to be approved to treat severe alopecia areata for children as young as 12 years in Europe. Ritlecitinib was approved in the United States and Japan in June 2023.
FDA Grants Priority Tag to Merck’s Welireg sNDA for New Indication: The FDA has accepted and granted priority review to Merck’s supplemental new drug application (sNDA) seeking approval for Welireg, a novel HIF-2α inhibitor, for previously treated patients with advanced renal cell carcinoma (RCC). The FDA is expected to give its decision on the sNDA on Jan 17, 2024. Welireg, at present, is approved to treat some von Hippel-Lindau disease-associated tumors. The sNDA was based on data from the phase III LITESPARK-005 study, which showed that treatment with Welireg led to a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies.
The FDA also granted a priority review tag to Merck’s supplemental biologics license application (sBLA) seeking approval for expanded use of Keytruda for an earlier stage of cervical cancer disease. The sBLA is seeking approval for Keytruda plus concurrent chemoradiotherapy as a treatment for patients with newly diagnosed high-risk locally advanced cervical cancer. With the FDA granting priority review to the sBLA, a final decision is expected on Jan 20, 2024. Keytruda is presently approved for two indications of cervical cancer. If the latest sBLA is approved, it would be Merck’s third approved indication in cervical cancer and the first for an earlier stage of cervical cancer.
The European Medicines Agency’s CHMP gave a positive opinion recommending approval of Keytruda for earlier-stage use in an NSCLC indication for patients in the European Union. The CHMP recommendation was for Keytruda as an adjuvant treatment for NSCLC patients who are at a high risk of recurrence following complete resection and platinum-based chemotherapy. The positive opinion was based on disease-free survival data from the phase III KEYNOTE-091 study. The European Commission’s final decision is expected in the fourth quarter of 2023. Keytruda was approved for similar use in the United States in January.
CHMP Nod to AstraZeneca’s Enhertu for HER2-Mutant NSCLC: The CHMP also recommended approving AstraZeneca and Daiichi Sankyo’s Enhertu in EU for previously treated patients with HER2-mutant advanced NSCLC. The recommendation was based on the objective response rate and duration of response from the DESTINY-Lung02 phase II study. Enhertu is already approved for a similar use in the United States.
The NYSE ARCA Pharmaceutical Index declined 2.67% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: EU Nod to PFE's Litfulo, FDA Priority Tag to MRK Applications
This week, the European Commission granted marketing approval to Pfizer’s (PFE - Free Report) Litfulo (ritlecitinib), an oral capsule to treat severe alopecia areata. The FDA granted priority review designation to Merck’s regulatory applications seeking approvals for expanded use of Merck’s (MRK - Free Report) Welireg and Keytruda. AstraZeneca’s (AZN - Free Report) Enhertu was recommended for approval in the EU by the Committee for Medicinal Products for Human Use (CHMP) for treating HER2-mutant non-small cell lung cancer (NSCLC).
Recap of the Week’s Most Important Stories
Pfizer’s Alopecia Areata Drug Gets Approval in Europe: The European Commission granted marketing authorization to Pfizer’s Litfulo (ritlecitinib), a once-daily oral capsule to treat adults and adolescents, aged 12 years and older, with severe alopecia areata. The approval was based on data from Pfizer’s ALLEGRO program on the candidate, which included the phase IIb/III ALLEGRO study. Lilly’s Olumiant (baricitinib) is also a once-daily pill approved in Europe for treating adult patients with severe alopecia areata. With the approval, Litfulo, a JAK inhibitor, became the first medicine to be approved to treat severe alopecia areata for children as young as 12 years in Europe. Ritlecitinib was approved in the United States and Japan in June 2023.
FDA Grants Priority Tag to Merck’s Welireg sNDA for New Indication: The FDA has accepted and granted priority review to Merck’s supplemental new drug application (sNDA) seeking approval for Welireg, a novel HIF-2α inhibitor, for previously treated patients with advanced renal cell carcinoma (RCC). The FDA is expected to give its decision on the sNDA on Jan 17, 2024. Welireg, at present, is approved to treat some von Hippel-Lindau disease-associated tumors. The sNDA was based on data from the phase III LITESPARK-005 study, which showed that treatment with Welireg led to a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies.
The FDA also granted a priority review tag to Merck’s supplemental biologics license application (sBLA) seeking approval for expanded use of Keytruda for an earlier stage of cervical cancer disease. The sBLA is seeking approval for Keytruda plus concurrent chemoradiotherapy as a treatment for patients with newly diagnosed high-risk locally advanced cervical cancer. With the FDA granting priority review to the sBLA, a final decision is expected on Jan 20, 2024. Keytruda is presently approved for two indications of cervical cancer. If the latest sBLA is approved, it would be Merck’s third approved indication in cervical cancer and the first for an earlier stage of cervical cancer.
The European Medicines Agency’s CHMP gave a positive opinion recommending approval of Keytruda for earlier-stage use in an NSCLC indication for patients in the European Union. The CHMP recommendation was for Keytruda as an adjuvant treatment for NSCLC patients who are at a high risk of recurrence following complete resection and platinum-based chemotherapy. The positive opinion was based on disease-free survival data from the phase III KEYNOTE-091 study. The European Commission’s final decision is expected in the fourth quarter of 2023. Keytruda was approved for similar use in the United States in January.
CHMP Nod to AstraZeneca’s Enhertu for HER2-Mutant NSCLC: The CHMP also recommended approving AstraZeneca and Daiichi Sankyo’s Enhertu in EU for previously treated patients with HER2-mutant advanced NSCLC. The recommendation was based on the objective response rate and duration of response from the DESTINY-Lung02 phase II study. Enhertu is already approved for a similar use in the United States.
The NYSE ARCA Pharmaceutical Index declined 2.67% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions
Image Source: Zacks Investment Research
In the last five trading sessions, while AbbVie rose the most (0.2%), Lilly declined the most (7.5%).
In the past six months, Lilly has risen the most (65.3%), while Pfizer has declined the most (17.8%).
(See the last pharma stock roundup here: FDA Nod to Updated PFE, MRNA COVID Jabs, & More)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.