Paratek announces COMP recommends orphan drug designation for NUZYRA

Paratek Pharmaceuticals announced that the European Medicines Agency, EMA Committee for Orphan Medicinal Products, COMP, has recommended a positive opinion for orphan medicinal product designation for NUZYRA for the treatment of nontuberculous mycobacterial lung disease. The COMP opinion applies to all species of NTM, including Mycobacterium abscessus and Mycobacterium avium complex. This designation will provide Paratek with protocol assistance for developing NUZYRA as an orphan medicine, 10 years market exclusivity once the medicine is on the market, data exclusivity, and the potential for fee reductions. “The COMP positive opinion on the recommendation to grant orphan drug designation for NUZYRA in the treatment of NTM lung disease represents a meaningful development for patients in Europe with this rare, difficult-to-treat, and debilitating condition,” said Randy Brenner, chief development and regulatory officer of Paratek. “Paratek is eager to work with regulators in the EU to align on a development program that would bring NUZYRA forward to address the significant unmet need for novel NTM treatments, especially oral antibiotics.”