FDA approves new Esbriet generic from Lupin for IPF

Treatment is latest to win approval, hit market since 2021

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by Andrea Lobo |

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The U.S. Food and Drug Administration (FDA) has approved a new generic version of Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF), according to an announcement by Lupin, the global pharmaceutical company that will market the medication.

As with the brand name medicine, Lupin‘s generic will be available in tablet form, at doses of 267 and 801 mg.

The new generic will be produced at the company’s Pithampur facility, located in India, according to Lupin.

The first generic of Esbriet, from Sandoz, was launched in May 2022, and several others have since followed.

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Pulmonary fibrosis is a disease characterized by scarring, or fibrosis, of the lungs, that leads to shortness of breath and other symptoms. In most cases, the exact cause of lung scarring is unknown, and the disorder is classified as idiopathic.

Esbriet is an approved oral treatment for IPF commercialized by Genentech, a member of the Roche group. It has been shown to slow disease progression, in part by blocking the activity of a pro-inflammatory molecule called transforming growth factor-beta (TGF-beta), which is known to be involved in lung scarring.

The therapy was first approved in the European Union in 2011, and in the U.S. in 2014. Its approvals were supported by data from three Phase 3 clinical trials comparing the effects of the medication against a placebo — ASCEND (NCT01366209), CAPACITY-004 (NCT00287716), and CAPACITY-006 (NCT00287729) — that together enrolled more than 1,000 people with IPF.

Results from these trials showed that treatment with Esbriet significantly slowed lung function decline, as measured by forced vital capacity — a parameter that measures the total amount of air a person can forcibly exhale after a deep breath. Treatment also reduced the risk of death by almost 50%.

The new generic medication has the same active ingredient as Esbriet, which is called pirfenidone. Several other companies, including Accord Healthcare, Teva, and Amneal, had Esbriet generics approved by the FDA last year following the agency’s positive decision on the Sandoz product.

Esbriet had been granted orphan drug designation by the FDA, which included seven years of market exclusivity upon its approval, which occurred in 2014. That exclusivity period ended in 2021, allowing generics of the medication to enter the market.

Generics are chemically identical to brand-name therapies. They usually contribute to bringing down the prices of medications by adding market competition.

Pirfenidone tablets had estimated annual sales totaling $218 million in the U.S., according to a report from IQVIA.

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