Novartis, Bayer, Roche score regulatory nods on 3 continents

A flurry of regulatory decisions around the world delivered a big new European approval for Bayer's Xarelto, an FDA nod for Novartis' new antibiotic for cystic fibrosis patients and a Japanese clearance for Roche's subcutaneous formulation of Actemra. Here are the details on these drugs, and more:

  • Novartis ($NVS) racked up an FDA approval for its inhaled antibiotic product TOBI Podhaler, for use in patients with cystic fibrosis. It's the first Pseudomonas aeruginosa fighter delivered in a handheld inhaler, rather than via a nebulizer. Report | Release

  • Bayer's anticoagulant Xarelto, already a big seller to prevent clots and strokes in certain patients, nabbed a recommendation for a potentially lucrative new use in Europe. The drug won a thumbs-up from the Committee for Medicinal Products for Human Use (CHMP) to treat ACS patients. It would be used to prevent heart attack, stroke and cardiovascular death in people with acute coronary syndrome. Report | Statement (PDF)

  • Bayer won another approval, this time in Japan, for its new colorectal cancer treatment Stivarga, a.k.a. regorafenib. The drug can be marketed for patients with advanced disease that can't be treated with surgery. Stivarga, developed with Onyx Pharmaceuticals ($ONXX), nabbed its FDA clearance last September. Release | Report

  • Roche's ($RHHBY) Japanese subsidiary Chugai said regulators there approved the subcutaneous version of Actemra, a treatment for rheumatoid arthritis. The drug has been available as an intravenous formula, but the subQ version works more quickly and can be administered at home. The formula is awaiting approval in the U.S. and Europe, so this is one of the few instances in which Japanese regulators beat their counterparts to the draw. Release | Report

  • Gilead Sciences ($GILD) won a CHMP recommendation for Stribild, its "quad" pill for HIV treatment. The drug, which combines four commonly used HIV fighters in one pill, was approved by FDA last year. Release (PDF)

In addition to the multiple sclerosis drug recommendations from CHMP, which we covered last week, two other drugs besides these won the committee's recommendation: Baxter's immunoglobulin drug HyQvia, and Ariad Pharma's ($ARIA) leukemia treatment Inclusig. Roche's MabThera won a thumbs-up for a new MabThera use, while Alexion's Soliris got an expanded indication for adults and children.

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