CHMP News – July 2015


Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU

At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU) and therefore outside Croatia.

Mosquirix was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU.

In addition, ten medicines were recommended for marketing authorisation in the EU. The recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation:

  • Praluent (alirocumab) was recommended for approval to lower 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. For more information on Praluent, please see the press release in the grid below.
  • 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. In its scientific opinion, the CHMP stressed that Intuniv, like other medicines authorised for the treatment of ADHD, must only be used as part of a comprehensive treatment programme typically incorporating psychological, educational and social measures. The CHMP also recommended that treatment with Intuniv must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
  • Cresemba (isavuconazole) received a positive opinion from the CHMP for the treatment of aspergillosis and mucormycosis. Cresemba has an orphan designation.
  • Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia and 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), received a positive opinion from the Committee for the treatment of post-operative pain. Hybrid applications rely in part on the results of studies carried out with a reference product and in part on new data.
  • Ivabradine Anpharm (ivabradine) was recommended for the treatment of stable chronic angina pectoris and chronic heart failure.
  • Two generic 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.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Qutenza, Revolade, Mekinist and Tafinlar.

Request for re-examination of negative CHMP recommendation for Heparesc

The marketing authorisation holder for Heparesc has requested a re-examination of the CHMP’s June 2015 negative opinion. Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine its opinion and issue a final recommendation.

Start of review

The CHMP has started a review of Inductos, an implant kit used in patients with spinal disc problems and leg fractures. Here you may read about it on the HALMED webpages.

For more information, please see the EMA’s webpages, or here.