Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 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).

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. For more information on Mosquirix and the Article 58 procedure, please see the press release and summary of opinion in the grid below.

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.

The Committee recommended granting a marketing authorisation for 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. For more information on Intuniv, please see the press release in the grid below.

Cresemba (isavuconazole) received a positive opinion from the CHMP for the treatment of aspergillosis and mucormycosis. Cresemba has an orphan designation.

The CHMP recommended granting a marketing authorisation for Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia and Obizur (susoctocog alfa) for the treatment of acquired haemophilia.

Zerbaxa (ceftolozane / tazobactam) received a positive opinion from the Committee for the treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections.

One hybrid medicine, 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. This medicine was submitted as an informed consent application. This means that the application makes use of the data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

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. For more information, please see the start of referral document in the grid below.

Agenda and minutes

The agenda of the July 2015 meeting is published on EMA's website. The minutes of the meeting will be published during the week following the next meeting of the CHMP which will take place from 21-24 September 2015. Minutes of the June 2015 CHMP meeting will be published next week.

CHMP statistics

Key figures from the July 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's July 2015 meeting, is available in the grid below.

CHMP highlights: July 2015

Positive recommendations on new medicines

Name of medicine	Cresemba
International non-proprietary name (INN)	isavuconazole
Marketing-authorisation applicant	Basilea Medical Ltd
Therapeutic indication	Treatment of aspergillosis and mucormycosis
More information	CHMP summary of positive opinion for Cresemba

Name of medicine	Fexeric
INN	ferric citrate coordination complex
Marketing-authorisation applicant	Keryx Biopharma UK Ltd
Therapeutic indication	Treatment of hyperphosphataemia
More information

Name of medicine	Intuniv
INN	guanfacine
Marketing-authorisation applicant	Shire Pharmaceuticals Ireland Ltd
Therapeutic indication	Treatment of Attention deficit hyperactivity disorder (ADHD)
More information	CHMP summary of positive opinion for Intuniv Press release: EMA recommends approval of treatment for attention deficit hyperactivity disorder

Name of medicine	Mosquirix
Common name	p. falciparum circumsporozoite protein fused with hepatitis B surface antigen (rts), and combined with hepatitis B surface antigen(s) in the form of non-infectious virus-like particles (vlps) produced in yeast cells (saccharomyces cerevisiae) by recombinant DNA technology
Marketing-authorisation applicant	GlaxoSmithKline Biologicals S.A.
Therapeutic indication	Active immunisation against malaria
More information	Press release: First malaria vaccine receives positive scientific opinion from EMA

Name of medicine	Obizur
INN	susoctocog alfa
Marketing-authorisation applicant	Baxalta Innovations GmbH
Therapeutic indication	Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor VIII
More information	CHMP summary of positive opinion for Obizur

Name of medicine	Praluent
INN	alirocumab
Marketing-authorisation applicant	sanofi-aventis groupe
Therapeutic indication	Treatment of adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) and mixed dyslipidaemia
More information	CHMP summary of positive opinion for Praluent Press release: Praluent recommended for approval to lower cholesterol

Name of medicine	Zerbaxa
INN	ceftolozane / tazobactam
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
Therapeutic indication	Treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections
More information	CHMP summary of positive opinion for Zerbaxa

Positive recommendation on new informed-consent application

Name of medicine	Ivabradine Anpharm
INN	ivabradine
Marketing-authorisation applicant	Anpharm Przedsiebiorstwo Farmaceutyczne S.A.
Therapeutic indication	Treatment of stable chronic angina pectoris and chronic heart failure
More information	CHMP summary of positive opinion for Ivabradine Anpharm

Positive recommendations on new generic medicines

Name of medicine	Pemetrexed Lilly
INN	pemetrexed
Marketing-authorisation applicant	Eli Lilly Netherlands
Therapeutic indication	Treatment of malignant pleural mesothelioma and non-small cell lung cancer
More information

Name of medicine	Pemetrexed Sandoz
INN	pemetrexed
Marketing-authorisation applicant	Sandoz GmbH
Therapeutic indication	Treatment of malignant pleural mesothelioma and non-small cell lung cancer
More information	CHMP summary of positive opinion for Pemetrexed Sandoz

Positive recommentation on new hybrid medicine

Name of medicine	Zalviso
INN	sufentanil
Marketing-authorisation applicant	Grunenthal GmbH
Therapeutic indication	Treatment of post-operative pain
More information	CHMP summary of positive opinion for Zalviso

Positive recommendations on new therapeutic indications

Name of medicine	Mekinist
INN	trametinib
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Mekinist

Name of medicine	Qutenza
INN	capsaicin
Marketing-authorisation holder	Astellas Pharma Europe BV
More information	CHMP post-authorisation summary of positive opinion for Qutenza

Name of medicine	Revolade
INN	eltrombopag / eltrombopag olamine
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Revolade