FDA tentatively approves generic selexipag as PAH treatment
Alembic’s formula is equivalent to Uptravi
The U.S. Food & Drug Administration (FDA) has tentatively approved Alembic Pharmaceuticals‘ generic formulation of injectable selexipag as a treatment for pulmonary arterial hypertension (PAH).
As a generic drug, which contains the same chemical substance as an approved treatment, it’s equivalent to Uptravi (selexipag) for injection (1,800 mcg/vial), sold by Johnson & Johnson.
Tentative approval means Alembic’s application met all the requirements for approval, but patents or exclusivities block final approval. The application contains a Paragraph IV certification under provisions of the Hatch-Waxman Act, which allows Alembic to seek FDA approval to market the generic drug before the expiration of brand-name drug patents.
With final approval, Alembic may be eligible to exclusively market its injectable selexipag in the U.S. for 180 days, or nearly six months, according to a company press release.
Pulmonary hypertension refers to high blood pressure in the arteries that pass blood through the lungs. Among the various causes of this high blood pressure is the narrowing of blood vessels that characterizes PAH. The disease is included in Group 1 of the World Health Organization (WHO) classification of pulmonary hypertension.
Treatment aims to lower blood pressure, ease symptoms
Selexipag, Uptravi’s active ingredient, is designed to bind to and activate the receptor for prostacyclin, a naturally occurring molecule found in the body that causes blood vessels to relax and widen. The medicine is intended to lower blood pressure, ease symptoms, delay disease progression, and reduce the risk of PAH-related hospitalization.
Uptravi, typically given as an oral treatment, was approved by the FDA in 2015, and in Europe and Canada the following year. In 2021, the therapy received FDA approval for an intravenous (IV), or into-the-vein, formulation for patients who are unable to take the oral treatment.
Data from two now-completed Phase 3 clinical trials, GRIPHON (NCT01106014) and TRITON (NCT02558231) established Uptravi’s efficacy compared with a placebo. An analysis of both trials showed that early treatment with the therapy within six months of PAH diagnosis cut the risk of disease progression in half over the placebo.
In another Phase 3 trial (NCT03187678), switching from oral to intravenous Uptravi was found to be safe and well tolerated. Patients reported mild side effects similar to those of the oral treatment.
Alembic’s request to market a generic intravenous version of selexipag was submitted in the form of an abbreviated new drug application. The treatment should be given as twice-daily, 80-minute infusions.
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