MYR Pharma has bagged Promising Innovative Medicine (PIM) status in the UK for Bulevirtide (myrcludex), its first-in-class entry inhibitor for the treatment of chronic hepatitis delta (HDV) infections.
The decision indicates that that the Medicines and Healthcare products Regulatory Agency (MHRA) believes the drug is a strong contender for the UK's Early Access to Medicines Scheme (EAMS), which gives patients with life threatening or seriously debilitating conditions access to medicines before they are approved for use in Europe.
In the second stage of the process, the Agency issues an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value, paving the way for patient access, opening up access before a regulatory decision is reached.
"Myrcludex was very well tolerated and has shown compelling antiviral activity in clinical trials performed so far," said Alexander Alexandrov, MYR's chief medical officer. "We are looking forward to working with the agency to accelerate the development program."
The first-in-class entry inhibitor has already received Orphan Designation for the treatment of HDV infection from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), PRIority Medicines scheme (PRIME) scheme eligibility from the EMA, and a breakthrough therapy designation from the FDA.
HDV is a virus that requires hepatitis B virus (HBV) for its replication. HDV infection occurs only simultaneously or as super-infection with HBV, and at least 5% of people with chronic HBV infection are co-infected with HDV, resulting in a total of 15 - 20 million persons infected with HDV worldwide.