Merck & Co/MSD has claimed FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer’s disease. Belsomra (suvorexant) has been approved since 2014 for treating insomnia in the general population characterised by difficulties with falling or staying asleep, becoming the first in a new class of drugs targeting
The European Commission (EC) has approved Merck and Pfizer’s Bavencio (avelumab), in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Both companies say that the approval made as a result of positive interim results from the Phase III JAVELIN Renal 101 study, which found that the combination
The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible
FDA has accepted Merck & Co’s anti-PD-1 therapy, Keytruda, in combination with Eli Lilly’s pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The regulators has also granted Priority Review to this application. This supplemental application is based on overall survival and progression-free survival (PFS) data
Merck’s Mavenclad is being backed by NICE as an option for treating highly active multiple sclerosis in adults on the NHS. In a Final Appraisal Determination, the cost watchdog is recommending routine funding for the drug if the patient has rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous
Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in
Regulators in the EU and US are reviewing three new submissions for medicines containing ertugliflozin, an investigational SGLT2 inhibitor being developed by Merck and Pfizer to aid improvement of glycaemic control in adults with type II diabetes.
For the first time in the EU, patients with a form of lung cancer will be able to get treatment with Merck & Co’s immunotherapy Keytruda as a first-line of attack instead of chemotherapy, following a green light from European regulators in this setting. The European Commission has approved Keytruda for the first-line treatment of
Merck and Pfizer’s bid to bring PD-1/PD-L1 inhibitor to market is now proceeding, after the EU regulator kicked off a review of avelumab for Merkel cell carcinoma. The drug’s marketing application is based on the results from the JAVELIN Merkel 200 study which were presented at this year’s ADCO meeting, from patients with the rare
Merck and Pfizer today announced that the FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) that have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the development and review of
