Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its July meeting.

The CHMP recommended granting marketing authorisations for two medicines for the treatment of advanced renal cell carcinoma (kidney cancer). Cabometyx (cabozantinib) and Kisplyx (lenvatinib) are indicated for the treatment of adult patients with advanced renal cell carcinoma who have been previously treated with a vascular endothelial growth factor (VEGF) inhibitor; Cabometyx is to be used as monotherapy while Kisplyx is for use in combination with everolimus. For more information, please see the press release in the grid below.

The Committee recommended granting a paediatric use marketing authorisation (PUMA) for Sialanar (glycopyrronium bromide) to treat severe drooling in children and adolescents with neurological disorders. This followed a re-examination of the Committee’s earlier negative opinion. PUMAs can be granted for medicines which are already authorised, but no longer under patent protection, and that have been developed specifically for children. This is the third time that the Committee has recommended a PUMA since the introduction of this type of marketing authorisationby the Paediatric Regulation, which came into force in 2007. Please see the questions and answers document in the grid below for more information on this opinion.

The Committee recommended granting a marketing authorisation for the orphan medicine Onivyde (irinotecan) for the treatment of metastatic adenocarcinoma of the pancreas.

Truberzi (eluxadoline) was recommended for approval for the treatment of irritable bowel syndrome with diarrhoea.

A generic medicine, Tenofovir disoproxil Zentiva (tenofovir disoproxil), was recommended for approval by the CHMP for the treatment of HIV-1 infection and chronic hepatitis B.

Two biosimilar medicines, Inhixa and Thorinane (both containing enoxaparin sodium), received positive opinions for the prevention and treatment of various disorders related to blood clots in adults.

Five recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Ameluz, Imbruvica,Orencia, Truvada and Xalkori.

A press release on the extension of indication for Truvada as pre-exposure prophylaxis (PrEP) against HIV-1 infection is available in the grid below.

CHMP confirms recommendations for use of Zydelig

The Committee confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects. However, following a review it has updated recommendations to minimise the risk of serious infections in patients treated with the medicine. For more information, please see the public health communication in the grid below.

CHMP recommends suspension of medicines over flawed studies at Semler Research Centre

The CHMP recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. For more information, please see the public health communication in the grid below.

Withdrawal of application

The application for a marketing authorisation for Begedina has been withdrawn. A questions and answers document on this withdrawal is available below.

Posted on the EMA website on 22 July 2016