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Meeting highlights from the Committee for Medicinal Products for Human Use, 22-25 September 2014

Fifteen new medicines and three extensions of indication recommended for approval

London, UK (September 26, 2014) – The Committee recommended a marketing authorisation for Harvoni (sofosbuvir / ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. Please see the press release for more information.

Ketoconazole HRA (ketoconazole) was recommended by the CHMP as a new treatment for patients with Cushing’s syndrome. Pharmacological options for this condition remain very limited and there is an unmet medical need for additional medicines. Ketoconazole HRA has an orphan designation. Please see the press release for more information.

Two medicines were granted a marketing authorisation by the CHMP for the treatment of cancer: Vargatef (nintedanib) for the treatment of non-small cell lung cancer and the orphan medicine Cyramza (ramucirumab) for the treatment of gastric cancer. The diagnostic agent Lymphoseek (tilmanocept) was also recommended for the delineation and localisation of sentinel lymph nodes.

Egranli (balugrastim) was recommended by the CHMP for the treatment of chemotherapy-induced neutropenia and Rezolsta (darunavir / cobicistat) received a positive opinion for the treatment of human immunodeficiency virus (HIV).

The CHMP also recommended Trulicity (dulaglutide) for the treatment of type 2 diabetes and Moventig (naloxegol) for the treatment of opioid-induced constipation.

The generic medicine Tadalafil Mylan was recommended by the Committee for the treatment of erectile dysfunction in adult males.

The CHMP granted positive opinions for the medicines Brimica Genuair and Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisations of both medicines.

Three hybrid applications received positive recommendations from the Committee: Budesonide / Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD, and Budesonide / Formoterol Teva Pharma B.V. for the treatment of asthma. The active ingredients in these medicines are budesonide and formoterol. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Three recommendations on extensions of therapeutic indications

The Committee recommended an extension of indications for Signifor and two extensions of indication for Prezista.

Outcome of re-examination procedure

The CHMP concluded a re-examination procedure for Avastin, adopting a final negative opinion on a request for an extension of indication in the treatment of adult patients with newly diagnosed glioblastoma.

Review underway concerning conduct of studies at GVK Bio Research Centre, India

The EMA has started a review in relation to findings of non-compliance with good clinical practice (GCP) at GVK Biosciences site in Hyderabad, India. This follows an inspection by the French medicines agency (ANSM) which raised concerns about study data used to support the marketing authorisation applications of generic medicines.

Outcome of benefit-risk review

The CHMP has completed a routine benefit-risk review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the Agency has recommended that further measures should be put in place to improve monitoring of liver function during treatment.

Closure of EU manufacturing site for MACI

The EU manufacturing site for the advanced therapy medicine MACI (matrix-applied characterised autologous cultured chondrocytes) has been closed for commercial reasons. Arrangements are in place for existing patients to complete their treatment. Please see communication in the grid on the website for further information.

Ebola outbreak: EMA to review experimental medicines to support treatment decisions

The EMA has started to review available information on Ebola treatments currently under development. The goal is to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities. Please see the press release for information.

Patients discuss benefit-risk evaluation of medicines with the CHMP

The EMA has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in CHMP meetings. Please see press release for more information.

Agenda and minutes

The agenda of the September 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the October CHMP meeting.

CHMP statistics

• Key figures from the September 2014 CHMP meeting are presented in the graphic at the link below.

• For an overview of all information available from the September CHMP, please click on the below link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/09/news_detail_002170.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency, 26.09.2014 (tB).