New Esbriet Generic PF Treatment Now Available In US
First approved by the U.S. Food and Drug Administration (FDA) in January, the treatment is now available and ready to be shipped, according to Accord.
“We’re proud to add this novel antifibrotic agent to our oral solids portfolio,” Sabitha Nair, vice president of regulatory affairs at Accord, said in a press release.
“IPF is a serious lung disease underdiagnosed and undertreated across the world that causes breathing problems as the disease progresses. With global vigilance surrounding the COVID-19 pandemic, concern for lung-related health is more urgent than ever,” Nair added.
Esbriet is an oral IPF treatment marketed by Genentech, a Roche company. It works by slowing the development of scar tissue, or fibrosis, in the lungs of IPF patients by blocking the activity of TGF beta, a pro-fibrotic molecule.
It was first approved in the U.S. in 2014, backed by data from three Phase 3 trials — ASCEND (NCT01366209), CAPACITY-004 (NCT00287716), and CAPACITY-006 (NCT00287729) — that showed its superiority over a placebo at slowing lung function decline and lowering patients’ risk of death.
Accord’s generic is a bio-equivalent of Esbriet, meaning it’s chemically identical to the brand name product. Since Esbriet’s clinical trials already established its safety and effectiveness, approval of any generics only requires proof of bio-equivalence, which Accord provided in an abbreviated new drug application (ANDA) submitted to the FDA in 2018.
Three other companies, Teva, Amneal, and Sandoz, have also gotten the green light from the FDA for their Esbriet generics this year, amidst ongoing litigation regarding patent infringement with Genentech.
Esbriet was granted orphan drug designation for IPF by the FDA in 2004, allowing it seven years of market exclusivity following approval. This market exclusivity expired in October, paving the way for new generics to enter the market. The addition of generic forms of medications adds market competition and typically drives down treatment prices.
As with Esbriet, Accord’s generic is supplied in 267 and 801 mg tablets. The recommended dosage is 801 mg three times daily. According to Accord, treatment may cause side effects including nausea, diarrhea, heartburn, or dizziness in some patients.