AstraZeneca, Merck & Co., and Astellas Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Otsuka Pharmaceutical.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 2, 2018 date to Tuesday May 8, 2018.
FDA OKs Astellas for New Combination Use of Overactive Bladder Drug Myrbetriq
The US Food and Drug Administration (FDA) has approved Astellas Pharma’s supplemental new drug application (sNDA) for the use of Myrbetriq (mirabegron) in combination with the muscarinic antagonist, VESIcare (solifenacin) succinate, for treating overactive bladder (OAB).
Both drugs are separately approved by the FDA as a monotherapy for OAB.
Myrbetriq, a beta‐3 adrenergic agonist, is indicated in combination with solifenacin succinate for treating OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Source: Astellas Pharma
EMA Approves AstraZeneca, Merck & Co.’s Lynparza for Ovarian Cancer
The European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300 mg twice daily) from AstraZeneca and Merck & Co., as a maintenance therapy for certain patients with ovarian cancer.
The drug was approved for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
Lynparza was initially licensed in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer. The new tablet formulation reduces dosing from eight capsules twice daily to two tablets twice daily.
Lynparza tablets were also recently submitted to the EMA for approval in patients with BRCA-mutated, HER2-negative metastatic breast cancer.
In July 2017, AstraZeneca and Merck & Co., entered into a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza for multiple cancer types. The companies are jointly developing Lynparza and selumetinib, the active ingredient in another AstraZeneca cancer drug, in combination with other potential new medicines and as a monotherapy. Independently, the companies are developing Lynparza and selumetinib in combination with their respective programmed death-ligand 1 (PD-L1) and PD-1 medicines.