Nine medicines recommended for authorisation, 93 overall in 2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine new medicines for marketing authorisation at its December 2015 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2015 to 93.

The CHMP recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC). The Committee reviewed Tagrisso under EMA’s accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. For more information, please see the press release in the grid below.

Another medicine for NSCLC, Portrazza (necitumumab), also received a positive opinion from the Committee.

Neofordex (dexamethasone), a medicine with an orphan designation, received a positive opinion for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application. This type of application relies in part on the results of studies carried out with a reference product and in part on new data.

The CHMP recommended granting a marketing authorisation for Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease.

Zurampic (lesinurad) received a positive opinion from the Committee for the treatment of hyperuricaemia (an excess of uric acid in the blood).

The CHMP recommended granting a marketing authorisation for Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B.

Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines.

One generic medicine received a positive opinion from the Committee: Caspofungin Accord (caspofungin) for the treatment of fungal infections.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Dropcys (mercaptamine hydrochloride) which was intended to prevent and treat cystinosis affecting the eye. For more information, please see the questions-and-answers document in the grid below.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Brilique, Nplate,Revolade, Tarceva and two extensions of indication for Cyramza.

New advice for doctors and patients on Gilenya

The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) and basal cell carcinoma in patients treated with the multiple sclerosis medicine Gilenya (fingolimod). For more information, please see the public health communication in the grid below.

Update on Xarelto

The CHMP is currently evaluating whether a defect with a blood clotting test device used in a study of the anti-clotting medicine Xarelto (rivaroxaban) had an impact on the study results. The study, called ROCKET-AF, was used to support the approval of Xarelto for patients with non-valvular atrial fibrillation (a type of irregular heartbeat). The CHMP expects to conclude its assessment in the first quarter of 2016. Once finalised, the CHMP assessment report will be made public.


Posted on the EMA website on 18 December 2015