Atyr Drug Candidate Given "Orphan" Status by European RegulatorsFriday, March 3, 2017
Local drugmaker aTyr Pharma has received a special regulatory classification in Europe for one of its drug programs, granting the company a number of perks.
The designation applies to aTyr’s program for Resolaris for the treatment of limb girdle muscular dystrophy, which causes weakness and limited mobility in voluntary muscles.
The company hopes that Resolaris, which is derived from a naturally-occurring protein, possesses the potential to reset the immune system in disease tissue to a more normal state.
The designation, called “Orphan Drug” status, gives the company a number of incentives, including assistance with the development of the drug, reduced fees for marketing authorization applications, and extended market exclusivity once the drug is approved. The designation is given to encourage the development of drugs for rare conditions. It was granted by the European Medicines Agency, the drug regulating body in Europe.
The company’s Resolaris program has now been granted Orphan Drug designation for two applications of the drug candidate from the FDA and the EMA. It’s also received the FDA's “Fast Track” designation, a regulatory status that helps speed development of the program.
“We are pleased with the development of Resolaris from a clinical and regulatory standpoint,” John Mendlein, CEO of aTyr, said in a statement. “We look forward to continuing to develop this potential therapy to help treat patients with these rare myopathies, for which there are limited or no treatment options, across the globe."