Latest Developments in the Pharmaceutical Industry: Regulatory Approvals, Legal Challenges, and Strategic Shifts
Leqembi Secures EU Authorization After Lengthy Regulatory Process
Eisai and Biogen have finally obtained European market authorization for their Alzheimer's drug Leqembi, following a prolonged regulatory journey. The European Medicines Agency (EMA) initially rejected the drug last summer but reversed its decision after an appeal from the companies. The European Commission, responsible for finalizing product clearances, requested the EMA to review new safety data, further delaying the evaluation process.
Under the newly granted authorization, Leqembi is approved for use in adults with mild dementia or cognitive impairment due to Alzheimer's, with specific genetic considerations. The approval restricts use to patients with one or no copies of the APOE4 gene, as those with two copies are believed to be at higher risk of experiencing ARIA, a known side effect of the treatment.
Legal Challenges and Patent Disputes in the Biosimilar Market
Sandoz, a prominent generic drug manufacturer, has initiated a new legal battle against Amgen over intellectual property rights protecting the blockbuster drug Enbrel. The federal lawsuit, filed in the Eastern District of Virginia, alleges anticompetitive practices by Amgen related to its 2004 exclusive licensing of patents originally held by Roche. These patents currently prevent biosimilar competition until 2029.
The lawsuit seeks to recover lost profits for Sandoz from 2021 until the filing date, with the potential for triple damages under antitrust law. Additionally, Sandoz aims to block Amgen's exclusive use of the patents. This legal action follows a previous unsuccessful attempt by Novartis, Sandoz's former owner, to invalidate Amgen's Enbrel patents in federal court.
Strategic Shifts and Pipeline Developments
Mural Oncology Explores Alternatives After Clinical Setbacks
Mural Oncology has announced it is exploring strategic alternatives following the failure of its experimental cancer treatment, nemvaleukin alfa, in two clinical studies. The drug did not meet its primary endpoint in a melanoma trial, shortly after the company halted another study in platinum-resistant ovarian cancer. As part of its strategic review, Mural plans to reduce its workforce by 90%.
Spruce Biosciences Pivots to Rare Disease Treatment
California-based Spruce Biosciences has announced a significant change in its development focus, shifting towards a new enzyme replacement therapy for Sanfilippo syndrome, a rare neurodegenerative disease. The company has acquired tralesinidase alfa, a drug candidate originally developed by BioMarin Pharmaceutical and later by Allievex. Spruce aims to submit an application for accelerated approval to the FDA in 2026. This strategic pivot follows the discontinuation of the company's previous lead drug candidate for a form of hyperplasia.
References
- Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents
After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sandoz is alleging Amgen's patent actions were anticompetitive.
Explore Further
What are the main safety concerns associated with Leqembi that led to the initial rejection by the EMA?
What potential impact could Sandoz's lawsuit against Amgen have on the biosimilar market for Enbrel before 2029?
What are the specific challenges faced by Mural Oncology in their clinical trials for nemvaleukin alfa?
How does Spruce Biosciences' focus on Sanfilippo syndrome compare to existing treatments or therapies?
What is the expected market demand for Leqembi in the EU given the genetic restrictions specified in the approval?