Pharma Stock Roundup: Regulatory Updates for Key Drugs<\/em><\/h3>\nThis week, the European Commission granted marketing approval to AbbVie<\/strong>\u2019s Tepkinly (epcoritamab) to treat relapsed or refractory (R\/R) diffuse large B-cell lymphoma (DLBCL). The FDA approved Lilly<\/strong>\u2019s diabetes drug, Jardiance (empagliflozin), for expanded use in chronic kidney disease (\u201cCKD\u201d).<\/p>\nThe FDA also accepted Sanofi\u2019<\/strong>s application seeking approval of its blockbuster medicine, Dupixent, for the use of eosinophilic esophagitis in kids and accepted and granted priority review to Merck<\/strong>\u2019s application seeking approval of pulmonary arterial hypertension (PAH)\u00a0candidate, sotatercept. J&J<\/strong>\u2019s study, evaluating a chemotherapy-free regimen\u00a0of its drug Rybrevant in first-line lung cancer, met its primary endpoint.<\/p>\nRecap of the Week\u2019s Most Important Stories<\/h3>\n
European Commission Approves AbbVie\u2019s Epcoritamab:<\/em><\/strong> The European Commission granted conditional marketing authorization to AbbVie\u2019s epcoritamab, to be marketed as Tepkinly, for treating R\/R DLBCL. The approval was based on the response rate and durability of response data from the expansion cohort of the phase I\/II study, EPCORE NHL-1.Epcoritamab was approved (accelerated approval) as Epkinly for certain patients with R\/R DLBCL in the United States in May.<\/p>\nFDA Approves Lilly\u2019s Jardiance for CKD: <\/em><\/strong>Lilly and partner Boehringer Ingelheim announced that the FDA has approved its diabetes medicine, Jardiance (empagliflozin), for the CKD indication.<\/p>\nJardiance 10 mg tablets are now approved to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD based on data from the EMPA-KIDNEY\u00a0phase III study. Data from the study showed that treatment with Jardiance, on top of the standard of care, led to a significant reduction in the risk of kidney disease progression and cardiovascular death in adults with CKD compared with placebo in addition to standard of care.<\/p>\n
Jardiance is already approved for use in certain patients with heart failure and type II diabetes in the United States and some other countries.<\/p>\n
FDA\u2019s Priority Tag to Sanofi\u2019s Dupixent sBLA for Eosinophilic Esophagitis in Kids: <\/em><\/strong>The FDA accepted and granted priority reviewto Sanofi\u2019s supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of eosinophilic esophagitis, a chronic inflammatory disease, in children (aged 1 to 11 years). The FDA is expected to give its decision on the sBLA on Jan 31, 2024.<\/p>\nThe sBLA was supported by data from the phase III EoE KIDS study. Dupixent was approved by the FDA for eosinophilic esophagitis in patients aged 12 years and above in May 2022. Dupixent is now approved to treat five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis, in both Europe and the United States.<\/p>\n
Sanofi\u2019s Altuviiio (efanesoctocog alfa), a once-weekly new class of factor VIII therapy for hemophilia A, was granted marketing authorization for hemophilia A in Japan. Altuviiio was approved in the United States in February 2023 and launched at the end of March.<\/p>\n
FDA Grants Priority Review to Merck\u2019s Sotatercept BLA:<\/em><\/strong> The FDA accepted and granted priority review to Merck\u2019s BLA\u00a0seeking approval of sotatercept for treating adult patients with pulmonary arterial hypertension \u00a0(WHO Group 1).\u00a0 The FDA\u2019s decision is expected on Mar 26, 2024. The BLA was based on data from the STELLAR study. In the study, sotatercept plus background therapy\u00a0significantly improved exercise capacity, increasing the six-minute walk distance by 40.8 meters from baseline at week 24, the study\u2019s primary endpoint. Moreover, sotatercept demonstrated statistically significant improvements in eight of nine secondary outcome measures, including a reduction in risk of clinical worsening or death.<\/p>\nMerck and its partner Eisai announced results from two late-stage clinical studies evaluating Merck\u2019s Keytruda plus Eisai\u2019s Lenvima in patients with certain types of metastatic NSCLC. Both studies, LEAP-006 and LEAP-008, failed to achieve their dual primary endpoints of overall survival (\u201cOS\u201d) and progression-free survival (\u201cPFS\u201d). The LEAP-006 and LEAP-008 studies also did not demonstrate a statistically significant improvement in objective response rate, a key secondary endpoint in both studies.<\/p>\n
At present, the combination of Keytruda plus Lenvima is approved for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. We remind investors that last month, Merck and Eisai, announced that they are closing a study evaluating a combination of Keytruda plus Lenvima for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma.<\/p>\n
J&J\u2019s Rybrevant First-Line NSCLC Study Meets Goal: <\/em><\/strong>J&J announced positive top-line data from the phase III MARIPOSA study evaluating Rybrevant (amivantamab) in combination with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor (TKI), versus osimertinib as a first-line treatment in EGFR-mutated NSCLC. The study met its primary endpoint by showing a statistically significant and clinically meaningful improvement in PFS in the Rybrevant\u00a0plus lazertinib arm compared to osimertinib. As far as OS data is concerned, a planned interim analysis showed a trend favoring the Rybrevant\u00a0and lazertinib combination compared to osimertinib.<\/p>\nAt present, Rybrevant is approved for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.<\/p>\n
The NYSE ARCA Pharmaceutical Index declined 1.09% in the last five trading sessions.<\/p>\n
In the last five trading sessions, while AstraZeneca rose the most (0.6%), J&J declined the most (3%).<\/p>\n
In the past six months, Lilly has risen the most (59.8%), while Pfizer has declined the most (20.5%).<\/p>\n
What’s Next in the Pharma World?<\/h3>\n
Watch out for regular pipeline and regulatory updates next week.
\nSanofi (SNY): Free Stock Analysis Report<\/p>\n
Johnson & Johnson (JNJ): Free Stock Analysis Report<\/p>\n
Merck & Co., Inc. (MRK): Free Stock Analysis Report<\/p>\n
Eli Lilly and Company (LLY): Free Stock Analysis Report<\/p>\n
AbbVie Inc. (ABBV): Free Stock Analysis Report<\/p>\n
To read this article on Zacks.com click here.<\/p>\n
Zacks Investment Research<\/p>\n
This article originally appeared on Zacks<\/i><\/p>\n
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