Eli Lilly’s ( LLY Quick Quote LLY - Free Report) candidate, solanezumab, failed to prevent Alzheimer’s in a study. Merck’s ( MRK Quick Quote MRK - Free Report) potential new PCSK9 inhibitor, MK-0616 significantly reduced low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol, compared to the placebo, in a study. The FDA accepted for review Sanofi ( SNY Quick Quote SNY - Free Report) and partner Regeneron’s regulatory application seeking label expansion of blockbuster medicine Dupixent (dupilumab) for a new indication. An FDA panel voted in favor of Roche’s ( RHHBY Quick Quote RHHBY - Free Report) Polivy combination for previously untreated diffuse large B-cell lymphoma (DLBCL). Recap of the Week’s Most Important Stories Lilly announced that its pipeline candidate solanezumab did not slow cognitive decline in people with preclinical Alzheimer's in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease (A4) study. Pre-clinical AD refers to those patients who have not shown any AD symptoms but have amyloid plaque. Lilly’s Pre-Clinical Alzheimer’s Disease Candidate Fails:
The candidate failed to reduce the risk of progression to symptomatic Alzheimer's disease in such individuals as it failed to clear brain amyloid plaque. With the A4 study failing to meet the primary and secondary endpoints, Lilly has stopped the clinical development of solanezumab. Lilly has donanemab and remternetug in its Alzheimer’s pipeline. Both are in late-stage stage development.
Solanezumab has failed in previous studies. In one such case, in 2016, solanezumab failed to slow disease progression in a late-stage study in patients with mild dementia due to AD.
The FDA accepted Lilly’s supplemental new drug application (sNDA) seeking approval for the expanded use of Jardiance for children 10 years and older with type II diabetes. The sNDA is based on results from the DINAMO phase III study.
Merck’s investigational oral PCSK9 inhibitor, MK-0616, significantly reduced LDL-C across all dose levels compared to placebo, in patients with hypercholesterolemia in a phase IIb study. At week 8, the placebo-adjusted reduction from baseline ranged from 41.2% to 60.9%. Merck plans to start a phase III pivotal study on the candidate in the second half of 2023 Merck’s Oral PCSK9 Inhibitor Lowers LDL-C in Study:
The FDA approved the intramuscular route of administration for Merck’s MMRV family of vaccines — M-M-RII, Varivax and ProQuad. Until now these vaccines were administered via subcutaneous injection.
The FDA accepted Sanofi’s supplemental biologics license application (sBLA) seeking the expanded use of blockbuster medicine Dupixent (dupilumab) for adults and adolescents aged 12 years and older with uncontrolled chronic spontaneous urticaria, an inflammatory skin condition. The FDA is expected to give its decision on Oct 22, 2023. The sBLA was supported by positive data from two phase III trials (LIBERTY-CUPID Studies A and B). FDA Accepts Sanofi’s Dupixent sBLA: An FDA advisory committee voted 11:2 in favor of the clinical benefit of the phase III POLARIX study on Polivy in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the first-line treatment of DLBCL. The FDA is expected to give its decision on Roche’s sBLA seeking the expanded use of Polivy for this indication by Apr 2, 2023. This Polivy combination is already approved for previously untreated DLBCL in countries like the EU, UK, Japan, Canada and China. In the United States and several other countries, Polivy in combination with bendamustine and MabThera/Rituxan is approved for relapsed or refractory DLBCL after one or more prior therapies FDA Panel Votes for Polivy Benefit in Phase III Study:
The NYSE ARCA Pharmaceutical Index declined 1.98% in the last five trading sessions.
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, Lilly rose the most (0.6%), while Novartis declined the most (6%).
In the past six months, Merck has risen the most (22.91%), while Pfizer has declined the most (17.5%).
(See the last pharma stock roundup here:
FDA Updates for SNY, PFE & Others, EU Nod to AZN Cancer Combo) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.