Merck, called MSD outside the US and Canada, has initiated a rolling submission to Health Canada for molnupiravir, an investigational oral antiviral therapy for the treatment of Covid-19.
Being developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an investigational, orally twice administered antiviral candidate that is currently in trials as a potential treatment for Covid-19.
This submission was accepted under the Minister of Health’s Interim Order and enables the review of early safety, quality and efficacy data while later-stage clinical trials take place.
The Phase III of the clinical trial, called MOVe-OUT, is currency underway to assess molnupiravir to treat non-hospitalised Covid-19 patients with at least one risk factor related to poor disease outcomes.
Health Canada will make a decision when all the necessary evidence from the ongoing molnupiravir development programme is submitted and reviewed.
In a separate development, the US Food and Drug Administration (FDA) has approved Merck’s hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor WELIREG (belzutifan) to treat patients with certain types of von hippel-lindau (VHL) disease-associated tumours.
The inhibitor is approved for VHL patients, who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNETs) but do not require immediate surgery.
The approval is based on the data obtained from the open-label Study 004 trial performed in 61 patients with VHL-associated tumors including RCC, CNS hemangioblastomas, and pNET.
In this trial, the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC.
WELIREG reduces transcription and expression of HIF-2α target genes that are associated with cellular proliferation, angiogenesis and tumor growth.
Merck Research Laboratories clinical research vice president Scot Ebbinghaus said: “WELIREG is the first and only approved systemic therapy for patients with certain types of VHL-associated tumors, representing an important new treatment option for patients affected by this rare condition.”