MYR Pharma announced 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. We are looking forward to working with the agency to accelerate the development program,
said Dr. Alexander Alexandrov,
MYR`s Chief Medical Officer.