With the new approval, patients with SSc-ILD in the European Union will now join those who currently have access to the medication in 15 other countries worldwide, including the U.S., Canada, Japan, and Brazil.
“The European Commission’s decision is very welcome news for the European scleroderma community,” Sue Farrington, president of the Federation of European Scleroderma Associations, said in a press release. “When scleroderma affects the lungs, there can be severe consequences. The availability of a therapy option brings great hope to those living with scleroderma and their loved ones.”
Marketed by Boehringer Ingelheim, Ofev is an approved therapy for the treatment of idiopathic pulmonary fibrosis (IPF) and other chronic ILDs. This group of lung disorders is characterized by inflammation and scarring in the tissue in and around the lung air sacs — known as the interstitium — which affects breathing.
The medication works by blocking proteins called growth factor receptors, which are involved in lung fibrosis (scarring) and produced in high levels in people with ILD.
Like previous approvals in other regions, the European Commission’s decision to approve Ofev to treat those with SSc-ILD in the EU was based on data from the Phase 3 SENSCIS trial (NCT02597933).
SENSCIS was a double-blind trial that investigated the safety and efficacy of Ofev in people with SSc-ILD. The study enrolled 576 patients from more than 100 sites across 32 countries worldwide. Participants were randomly assigned to receive twice-daily capsules containing 150 mg of Ofev, or a placebo, over one year.
The study’s main goal was to assess the annual decline in forced vital capacity — a lung function parameter that measures the amount of air a patient is able to exhale after taking a deep breath.
Results showed that Ofev slowed lung function decline by 44% over one year compared with the placebo.
In addition, treatment was well-tolerated, with more than 80% of participants successfully completing the trial. Diarrhea, the most common adverse event reported during the study, was more frequent among those receiving Ofev than those given a placebo.
Ofev’s safety profile in patients with SSc-ILD was similar to that observed in people with IPF.
“This is a real breakthrough in the treatment of people living with SSc-ILD,” said Peter Fang, senior vice president and head of therapeutic area inflammation at Boehringer Ingelheim. “Once fibrosis of the lungs occurs it cannot be reversed. [Ofev], being the first and only approved treatment for SSc-ILD, is serving a high unmet need making a real positive difference to those living with this life-changing condition. The approval is a further milestone in Boehringer Ingelheim’s ongoing dedication for people living with pulmonary fibrosis.”
The company is now conducting an open-label extension study (NCT03313180) to evaluate Ofev’s long-term safety in people with SSc-ILD.
Boehringer Ingelheim has a patient support program to help those prescribed Ofev, as well as their caregivers. The Open Doors program provides a range of nursing, social resources, and financial support services.
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