“Receiving PRIME designation for sotatercept from the EMA mere weeks after the FDA granted it Breakthrough Therapy designation further strengthens our belief that sotatercept could eventually alter the treatment landscape in PAH dramatically,” said Habib Dable, President and Chief Executive Officer of Acceleron. “We’re delighted that in their initial assessments of our clinical trial data, regulatory authorities in the US and Europe have put forth a path that could potentially help us expedite delivery of sotatercept to patients in need of new therapeutic options.”
Launched in 2016, the EMA’s PRIME program is designed to enhance support for the development of medicines that target an unmet medical need and focuses on medicines that, based on early clinical data, may offer a major therapeutic advantage over existing treatments or may benefit patients without treatment options. PRIME offers drug developers the potential for accelerated assessment, access to scientific advice, and guidance on overall development plans and regulatory strategy as a means to help patients benefit as early as possible from therapies that may significantly improve their quality of life.
In 2019, the FDA granted Orphan Drug designation for sotatercept in PAH.
Source: Company Press Release