This week AstraZeneca AZN/Merck’s MRK PARP inhibitor Lynparza was approved in the European Union for first-line pancreatic cancer. Merck provided two regulatory updates related to label expansion filings of its blockbuster medicine Keytruda. GlaxoSmithKline GSK signed yet another deal with a private vaccine maker to make a COVID-19 vaccine candidate using its pandemic adjuvant technology.
Recap of the Week’s Most Important Stories:
AstraZeneca/Merck’s Lynparza Get EU Approval for Pancreatic Cancer: The European Commission granted marketing approval to Lynparza as a first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer. The recommendation was based on data from the phase III POLO study. Lynparza was approved in the United States for this patient population in December last year.
Meanwhile, the FDA granted priority review status to a supplemental new drug application (sNDA), seeking approval of blood thinner Brilinta for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA). The FDA’s decision is expected in the fourth quarter of 2020. The sNDA was based on data from the phase III THALES study, In June, Brilinta was approved by the FDA for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease based on data from the phase III THEMIS study.
Updates on Keytruda from Merck: The FDA issued a complete response letter to Merck and Eisai’s applications seeking approval of Keytruda+Lenvima combination for the first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The CRL said that the regulatory applications did not provide enough evidence that the Keytruda+Lenvima combination shows any meaningful advantage over existing drugs for unresectable or metastatic HCC in patients who have not received prior systemic therapy. Merck and Eisai plan to conduct an additional study, which will provide proof of effectiveness and benefit of the combination drugs in this patient population
Meanwhile, the FDA accepted and granted priority review status to a sBLA seeking approval of Keytruda for second-line treatment of patients with relapsed or refractory classical hodgkin lymphoma. With the FDA granting priority review to the application, a decision is expected on Oct 30.
Glaxo’s New Collaboration for Adjuvanted COVID-19 Candidate: Glaxo announced yet another collaboration, this time with privately-held Medicago to develop novel adjuvanted COVID-19 candidate vaccine. Phase I testing of the vaccine will begin in mid-July. Glaxo has formed several similar collaborations to make its pandemic adjuvant technology available to partners who are making adjuvanted COVID -19 vaccine candidates. The latest deal combines Medicago’s innovative plant-based antigen technology with Glaxo’s pandemic adjuvant system. The companies plan to make the vaccine available by first half of 2021. The pandemic adjuvant can reduce the amount of vaccine protein required per dose, which, in turn, will allow more vaccine doses to be produced. It can also increase the immune response of the vaccines, thereby providing better immunity.
FDA Approves Expanded Label of AbbVie’s Botox for Pediatric Spasticity: The FDA granted approval to AbbVie’s ABBV Botox to treat spasticity in pediatric patients (2 years of age and older) including those with lower limb spasticity caused by cerebral palsy. Last year, Botox was approved by the FDA for both lower and upper limb spasticity in pediatric patients, excluding lower limb spasticity caused by cerebral palsy. Meanwhile, Botox is already approved for both lower and upper limb spasticity in adults.
The NYSE ARCA Pharmaceutical Index declined 0.6% in the last four trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last four trading sessions.
Last week, while Roche RHHBY recorded the highest increase (1.7%), Pfizer PFE declined the most (2.6%).
In the past six months, Lilly LLY risen the most (19.8%) while Pfizer declined the most (15.1%).
(See the last pharma stock roundup here: PFE’s Coronavirus Vaccine Study, Approvals in Focus)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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