- The European Commission on Thursday approved label expansions that broaden the market for key therapies from pharma companies Roche and Merck, mirroring similar U.S. regulatory decisions from last year.
- Roche's Hemlibra was approved for prevention of bleeding episodes in patients with severe hemophilia A without Factor VIII inhibitors.
- And Merck & Co. won clearance for Keytruda in combination with chemotherapy for previously untreated adults with metastatic squamous non-small cell lung cancer.
Both Hemlibra (emicizumab) and Keytruda (pembrolizumab) are key drugs for their makers.
Roche is counting on Hemlibra to help boost revenue as it faces competition to its top three cancer drugs. An earlier approval in the EU had cleared the drug for use in a limited, more severe patient population.
Even with the narrower approval, the hemophilia medicine had already shaken up a market that includes Novo Nordisk's NovoSeven (coagulation Factor VIIa, recombinant) and Shire's Feiba (anti-inhibitor coagulant complex).
The investment bank Jefferies estimates annual Hemlibra sales will peak at $5 billion a year. Much of that forecast is tied to the drug's potential in patients both with and without inhibitors.
People with hemophilia A either don't have enough of the clotting protein called Factor VIII or lack it altogether. The original group of patients that Hemlibra won approval for — those with inhibitors — have developed antibodies that inhibit standard Factor VIII replacement therapies.
Hemophilia A affects about 320,000 people around the world, at least half of whom have a severe case, according to Roche's statement Thursday.
Merck, meanwhile, is getting a shot at a bigger EU market for Keytruda, an immunotherapy that can now be used as a frontline treatment in patients with metastatic squamous non-small cell lung cancer. NSCLC is by far the most common type of lung cancer, which killed almost 388,000 people in Europe last year, according to Merck's statement Thursday.
Most non-small cell lung cancer cases are classified as non-squamous, while roughly a quarter are the harder-to-treat and more aggressive squamous type.
Keytruda is already the primary driver of growth for Merck revenue. Sales jumped 88% last year to reach $7.2 billion. And the company is working to expand Keytruda's use even further, with almost half of its 20 late-stage clinical trials focused on the medicine.
The latest European approval was based on results from a KEYNOTE-407, which showed an overall survival benefit for Keytruda.