San Ramon, California and Rehovot, Israel-based SteadyMed Ltd recently announced the submission of an Orphan Drug Designation application to the United States Food and Drug Administration (FDA) for Trevyent, its lead product to address pulmonary arterial hypertension (PAH).
The FDA received the application and will notify the company as soon as the review process is completed. If the FDA grants Orphan Drug Designation, Trevyent would be eligible for several key incentives, including a waiver of New Drug Application submission fees, tax credits, the possibility of a priority review upon filing of its New Drug Application submission, and a 7-year period of exclusivity to market the product once approval is granted.
“SteadyMed continues to execute on our strategic goals including our submission of this request for Orphan Drug Designation. We look forward to a decision from the FDA as we continue to drive to submission of an NDA for Trevyent in the first quarter of 2016,” said the CEO and President of SteadyMed, Jonathan M. N. Rigby.
An Orphan Drug Designation can be granted by the FDA for biological products or drugs that address treatment to rare diseases; rare diseases are those that affect less than 200,000 people in the United States. Orphan Drug Designation might also be given to biologic products or drugs that show clinical superiority in comparison to an already approved drug currently used to treat an orphan disease.
PAH is a progressive, rare and life-threatening disease that can cause heart failure and premature death. About 30,000 individuals in the United States are diagnosed with PAH currently.
In other PAH-related news, Actavis recently confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking approval to commercialize their formulation of Ambrisentan Tablets (5 and 10 mg). This drug is a generic version of Letairis® from Gilead Sciences, Inc. to address treatment for pulmonary arterial hypertension.
Supported by newly available information, Actavis thinks this might be the first application of an ANDA for a generic version of Letairis®, and it should be approved to potentially offer 180 days of generic market exclusivity to the company.