Boehringer Ingelheim's Ofev scores FDA nod as first treatment for rare lung disease

Boehringer Ingelheim's Ofev got a nod from the FDA to treat interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD). (Boehringer Ingelheim)

Boehringer Ingelheim rode rare lung disease med Ofev to serious sales growth last quarter, and it’s looking to keep that trend going. Could a new, competition-free lung disease indication be the boost the drugmaker is looking for?

The FDA Friday approved Ofev to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD). 

Scleroderma is a rare disease that causes tissue throughout the body, including the lungs and other organs, to thicken and scar, according to a release from the agency. One of the most common forms of the disease is SSc-ILD, which affects the interstitium—part of the lung’s structure.

Ofev is now the only drug approved to treat the disease, which is thought to affect around 50,000 individuals in the U.S., the FDA said.

The drug got its approval after receiving a Priority Review designation from the FDA as well as Orphan Drug status as a treatment for a rare disease indication.

Ofev’s nod follows a phase 3 clinical trial, dubbed Senscis, in which the drug beat out placebo in terms of slowing the decline of forced vital capacity (FVC)—a measure of lung function—in 576 patients treated a minimum of 52 weeks and maximum of 100 weeks.  

RELATED: Boehringer pharma chief heads for the exit amid a top-level reshuffling

The newest win for Ofev comes as Boehringer reworks its executive team, including the departure of an executive who played a “critical” role in pushing Ofev to its initial FDA approval in 2014.

Earlier this month, the drugmaker said Allan Hillgrove, a 37-year Boehringer veteran responsible for the company’s human pharma and biopharma businesses, would retire at the end of 2019.

In a statement, Christian Boehringer, chairman of the shareholders’ committee, said Hillgrove had been key in driving the drugmaker’s respiratory and diabetes portfolios to market, including Ofev. In the second quarter, the drug hit €677 million in sales, a 21.6% jump from the same period in 2018.

Hillgrove is set to be replaced by Carine Brouillon, who heads Boehringer’s therapeutics meds department, both at the pharma helm and on Boehringer's board. She'll take both roles beginning January 1. Brouillon has been with Boehringer since 2018.

Boehringer will also say goodbye to Joachim Hasenmaier, who has led the company’s animal health business since 2001, when he retires and steps down from the board. Andreas Neumann, an eight-year Boehringer vet, is also departing and stepping down from the board this month.