EU body endorses 11 new drugs from Glaxo, Roche, J&J and others

A European Union regulator has recommended approval of 11 new drugs for a range of diseases such as HIV, breast cancer and diabetes. And the nods could lead to final approvals from the European Commission in the coming months.

Many of the drugs have already gained FDA approvals, yet the European Medicines Agency noted that the 11 recommendations for approval from its Committee for Medicinal Products for Human Use (CHMP) mark the most nods in a single meeting this year.

For several pharma groups, the medicines that have garnered CHMP endorsements play crucial roles in key business areas.

  • GlaxoSmithKline ($GSK), which counts on sales of respiratory meds more than any other category, and partner Theravance ($THRX) won a positive recommendation for Relvar Ellipta. The CHMP gave advised the EC to approve the LAMA/LABA combo for both asthma and chronic obstructive pulmonary disease (COPD). The FDA approved the drug, marketed as Breo Ellipta in the U.S., for COPD only in May. Also, Japan's drug regulator stamped an approval on Relvar for asthma patients this week.
  • Johnson & Johnson ($JNJ) snagged the CHMP's endorsement for Invokana, which belongs to a class of drugs called SGLT2 inhibitors, for treating Type 2 diabetes. In March the FDA approved Invokana, a foundational product for J&J in the market for diabetes drugs. It was the first SGLT2 blocker approved in the U.S.
  • Roche ($RHHBY), the world's largest provider of cancer drugs, gained a positive opinion from CHMP for Kadcyla as a treatment for breast cancer. The product marries the Roche's antibody drug Herceptin (trastuzumab) with drug-conjugate technology from ImmunoGen ($IMGN). Roche faces biosimilar competition in coming years for Herceptin, yet Kadcyla has shown benefits over the former drug in clinical trials and could aid the company in keeping an edge over rivals.
  • Gilead Sciences' ($GILD) Vitekta gained an endorsement for the treatment of adults with HIV-1, giving the Foster City, CA-based biotech powerhouse another victory for its world-leading HIV franchise.

Other CHMP nods for new drugs went to Novo Nordisk ($NVO) for its hemophilia therapy called NovoEight; Otsuka's Abilify Maintena for schizophrenia; Algeta and Bayer's Xofigo for prostate cancer; Plethora Solutions' lidocaine/prilocaine for treating premature ejaculation in men; and the flu vaccine Fluenz Tretra from AstraZeneca's ($AZN) MedImmune.

- here's the EMA's bulletin

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