Two new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting.

The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

The generic medicine Tigecycline Accord (tigecycline) received a positive opinion for the treatment of complicated skin and soft tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for AlunbrigOfev and Otezla.

The CHMP also recommended the addition of a new pharmaceutical form for Entyvio: a 108 mg solution for injection to be given subcutaneously.

Negative opinion on extension of therapeutic indication

The CHMP adopted a negative opinion for an extension of indication for Emgality (galcanezumab) to add prevention of attacks in adults who suffer from episodic cluster headache.

Start of referrals

The CHMP started a review of medicines for which studies have been conducted by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. This follows a good clinical practice (GCP) inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the EU.

The Committee also started a review of the cancer medicine Yondelis (trabectedin), used to treat ovarian cancer and soft-tissue sarcoma (a type of cancer that develops from the soft, supporting tissues of the body). The review started after a clinical study (OVC-3006) investigating the use of Yondelis in patients with ovarian cancer was stopped ahead of time, because an interim analysis of the results showed that, overall, patients treated with Yondelis plus pegylated liposomal doxorubicin (PLD, another cancer medicine) did not live longer than patients given PLD alone.

Withdrawals of applications

The application to extend the use of Axumin (fluciclovine (18F)) in the diagnosis and continuing assessment of glioma (a type of brain tumour) was withdrawn.

The application for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in the treatment of metastatic non-small cell lung cancer that has not been treated previously was also withdrawn.

Posted on the EMA website on 28 February 2020