FDA grants orphan drug status to arGentis for sclerosis drug

MEMPHIS, Tenn. arGentis Pharmaceuticals has received orphan drug designation for its systemic sclerosis drug ARG201 from the Food and Drug Administration.

The drug treats the disease, which attacks the body’s own type 1 collagen causing fibrosis of the skin, lungs and other organs. As the disease progresses, patients suffer increasing difficulties with digestion, breathing, joint pain and often develop pulmonary hypertension.

The designation from the FDA gives the company seven years of marketing exclusivity for the drug upon approval. It also gives arGentis the opportunity to apply for grant funding from the government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA’s application user fee.