SAN DIEGO, Feb. 28, 2017 /PRNewswire/ -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy (LGMD) patients.
"Receiving Orphan Drug Designation for the treatment of all types of LGMD patients with Resolaris is an important step in our overall process of bringing our first Physiocrine-based product candidate to the market to treat patients," said John Mendlein, CEO of aTyr Pharma. "This designation follows our recently granted Fast Track designation and our promising signals of clinical activity in a LGMD sub-type (LGMD2B). We are excited to continue the development of Resolaris to treat patients with rare myopathies with an immune component who currently have limited or no therapeutic treatment options."
The FDA's Orphan Drug Designation program is intended to advance the development of products which demonstrate promise in diagnosing or treating rare conditions that affect fewer than 200,000 people in the U.S. Sponsors developing orphan-designated products are eligible for incentives under the program, including seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and certain tax credits.
aTyr Pharma is developing Resolaris as a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris is derived from a naturally occurring protein released by human skeletal...