BURGWEDEL, Germany, March 5, 2019 /PRNewswire/ -- MYR Pharma announced today that the British Medicines and Healthcare productsRegulatory Agency (MHRA) has issued the Promising Innovative Medicine (PIM) designation for MYR's lead compound Bulevirtide (Myrcludex). The designation is granted in the indication of chronic hepatitis delta virus (HDV) infection. A PIM designation
"All existing data indicate that Bulevirtide is a safe and tolerable product. Throughout all clinical trials performed so far, Bulevirtide has shown compelling antiviral activity," said Dr. Alexander Alexandrov, MYR`s Chief Medical Officer. "We are looking forward to working with the agency to accelerate the development program."
About BulevirtideBulevirtide (Myrcludex) is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the NTCP receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. Bulevirtide has received Orphan Drug designation for treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility - by this designation EMA offers early and proactive support for the development of medicines that target an unmet medical need. In parallel the FDA has granted Breakthrough Therapy designation - a process designed to expedite the development and review of drugs which may demonstrate substantial improvements on a clinically significant endpoint.
About MYR PharmaMYR Pharma is a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of patients with chronic hepatitis B and D virus infections. The company's lead compound progresses into a Phase 3 study in the indication of chronic HDV infection.
Contact DetailsThomas ChristélyPhone: +49 (0)6172-4959811Email: firstname.lastname@example.org
View original content:http://www.prnewswire.com/news-releases/myr-pharma-announces-grant-of-promising-innovative-medicine-pim-designation-by-british-mhra-for-bulevirtide-myrcludex-the-first-in-class-entry-inhibitor-for-treatment-of-chronic-hepatitis-d-infections-300806926.html
SOURCE MYR Pharma
Subscribe to our Free Newsletters!