On 28 May 2020, the European Medicines Agency (EMA), via its Committee for Medicinal Products for Human Use (CHMP), adopted a positive opinion of Hepcludex. This drug is intended for the treatment of chronic hepatitis delta virus (HDV) infection in adult patients with compensated liver disease, and effectively reduces HDV RNA levels and signs of liver inflammation in treated patients.
CPC Scientific serves as a supplier and partner to the organization responsible for developing bulevirtide (Hepcludex), MYR Pharmaceuticals. With the compound’s commercial launch scheduled for 1 September, 2020 and the EMA expected to issue its central conditional marketing authorization within 67 days, we celebrate a hard-won success with our MYR colleagues! This victory was purchased with long hours and unending insight from both teams, and our respect and appreciation for all contributors cannot be overstated.
Hepcludex is classified as an orphan medicine, a designation reserved for APIs developed for use against rare, life-threatening, or chronically debilitating conditions or which, for economic reasons, would be unlikely to have been developed without aid. Approximately 4 in 10,000 people in the European Union (EU) are affected by the hepatitis delta virus infection (totaling around 205,000 individuals): a segment small enough to be overlooked by the research community at large. It is CPC’s honor to work towards the alleviation of human suffering on any scale, and an additional privilege to work with like-minded partners like MYR Pharmaceuticals.
Congratulations to MYR Pharmaceuticals, and we look forward to a long and happy partnership!
