Sandoz Launches Treprostinil Injection, First Remodulin Generic, in the US for PAH Treatment

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by Santiago Gisler |

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Sandoz Treprostinil

The pharmaceutical company Sandoz announced the commercialization of an injectable form of the vasodilating therapy treprostinil for treating exercise-related symptoms affecting individuals with pulmonary arterial hypertension (PAH).

This treprostinil injection is the first generic substitute (the non-branded version of a developed therapy) of Remodulin, developed and sold by United Therapeutics. Sandoz, the generics division of Novartis, received 180 days of market exclusivity for the therapy, which are marketing rights granted by the U.S. Food and Drug Administration (FDA).

“Pulmonary arterial hypertension is a rare disease that primarily affects women, many in their 30s and 40s, and can have a significant impact on their quality of life as it worsens over time,” Carol Lynch, president of Sandoz, said in a press release.

“At Sandoz, we believe in reimagining the care of patients by bringing complex generics, like treprostinil, to U.S. patients and providing access to cost-effective, high-quality medicines,” Lynch added.

Join the PH forums: an online community especially for patients with pulmonary hypertension.

The prostacyclin analog treprostinil is a so-called vasodilator, which means that it widens the blood vessels and thereby can lower the blood pressure associated with artery narrowing in PAH. The FDA approved Remodulin in 2002 based on its beneficial effects on exercise and shortness of breath in PAH patients.

According to a recent study, treprostinil is able to stop arterial wall vessel remodeling by inhibiting the release of growth factors, proliferation of cells, and deposits of collagen in the arteries’ walls. Treatment of cells collected from PAH patients with treprostinil resulted in reduced proliferation of arterial muscle cells, and deposition of extracellular matrix proteins outside the cells, which are hallmarks of PAH.

Sandoz is now collaborating with RareGen — a marketing support company specializing in rare diseases — to commercialize treprostinil injections. The formulation will be available in 20 mL multidose vials containing 20, 50, 100, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL).

Three treprostinil-based therapies marketed by United Therapeutics are already approved by the FDA in the U.S. These include Remodulin (injectable formulation), Tyvaso (inhaled formulation), and Orenitram (oral extended-release formulation).

For more information about treprostinil injections, including indications, usage, and side effects, Sandoz directs patients to Dailymed, run by the U.S. National Library of Medicine.

A Conversation With Rare Disease Advocates