BURGWEDEL, Germany, March 5, 2019 /PRNewswire/ -- MYR Pharma announced today that the British Medicines and Healthcare products Regulatory 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 is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), in the treatment, diagnosis or prevention of life-threatening or serious debilitating conditions with unmet medical need. With the designation, the MHRA confirms that Bulevirtide is likely to offer major advantage for chronic HDV patients.
"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."
Bulevirtide (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 Pharma
MYR 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.
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SOURCE MYR Pharma