Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020

News 28/02/2020

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 Alunbrig, Ofev 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.

For more information on this negative opinion, see the question-and-answer document in the grid below.

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.

For more information, see the start-of-referral documents in the grid below.

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.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the February meeting is published on EMA's website. Minutes of the January 2020 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the February 2020 CHMP meeting are represented in the graphic below.

CHMP statistics: February 2020

Positive recommendation on new medicine

Name of medicineFetcroja
International non-proprietary name (INN)cefiderocol
Marketing-authorisation applicantShionogi B.V.
Therapeutic indicationTreatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options
More informationFetcroja: Pending EC decision


Positive recommendation on new generic medicine

Name of medicineTigecycline Accord
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of complicated skin and soft tissue infections and complicated intra-abdominal infections 
More informationTigecycline Accord: Pending EC decision


Positive recommendations on extensions of indications

Name of medicineAlunbrig
Marketing-authorisation holderTakeda Pharma A/S
More informationAlunbrig: Pending EC decision


Name of medicineOfev
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More informationOfev: Pending EC decision


Name of medicineOtezla
Marketing-authorisation holderAmgen Europe B.V.
More informationOtezla: Pending EC decision


Negative recommendation on extension of indication

Name of medicineEmgality
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationEmgality: Pending EC decision


Important recommendation on new strengths, formulations or routes of administration

Name of medicineEntyvio
Marketing-authorisation holderTakeda Pharma A/S
More informationEntyvio: Pending EC decision


Start of referrals

Name of medicinePanexcell Clinical Laboratories Priv. Ltd
More informationPanexcell: Article-31 referral


Name of medicineYondelis
More informationYondelis: Article-20 procedure


Withdrawals of extensions of indications

Name of medicineAxumin
INNfluciclovine (18F)
Marketing-authorisation holderBlue Earth Diagnostics Ireland Ltd
More informationAxumin: Withdrawn application


Name of medicineOpdivo / Yervoy
INNnivolumab / ipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information

Opdivo: Withdrawn application

Yervoy: Withdrawn application


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