Green light for new medicines

by Gary Finnegan: The European Medicines Agency’s influential Committee for Medicinal Products for Human Use (CHMP) has given the green light for ten new medicines, as well as offering a positive scientific opinion on the world’s first malaria vaccine.

The positive review of Mosquirix (Plasmodium falciparum and hepatitis B vaccine) moves the breakthrough vaccine one step closer to being used outside the European Union (EU). The vaccine was reviewed under a special regulatory procedure known as Article 58 which allows the EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, even though it will not be marketed in Europe.

In addition, ten medicines were recommended for marketing authorisation in the EU:

• Praluent(alirocumab) for lowering high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins.
• Intuniv (guanfacine) to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years old for whom stimulants, another type of ADHD medicines, are not suitable or tolerated or have shown to be ineffective.
• Cresemba(isavuconazole) for the treatment of aspergillosis and mucormycosis. Cresemba has an orphan designation.
• Fexeric(ferric citrate coordination complex) for the treatment of hyperphosphataemia
• Obizur(susoctocog alfa) for the treatment of acquired haemophilia.
• Zerbaxa(ceftolozane / tazobactam) for the treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections.
• Zalviso(sufentanil) for the treatment of post-operative pain.
• Ivabradine Anpharm(ivabradine) for the treatment of stable chronic angina pectoris and chronic heart failure.
• Twogeneric medicines received positive opinions from the CHMP: Pemetrexed Lilly (pemetrexed) and Pemetrexed Sandoz (pemetrexed) for the treatment of malignant pleural mesothelioma and non-small cell lung cancer.