Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

News 16/11/2018

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting.

The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines for use outside the European Union. For more information, please see the press release in the grid below.

Erleada (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.

The CHMP recommended granting a marketing authorisation for Macimorelin Aeterna Zentaris (macimorelin), for the diagnosis of growth hormone deficiency in adults.

The generic medicine Silodosin Recordati (silodosin) received a positive opinion from the CHMP for the treatment of the signs and symptoms of benign prostatic hyperplasia.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Kisqali, Mabthera, Orkambi and Ravicti.

Positive recommendations on extension of therapeutic indication following re-examination

The Committee recommended an extension of therapeutic indication for Blincyto (blinatumomab) in patients with residual cancer cells in the body after previous treatment, after re-examining its negative opinion for this medicine adopted in July 2018.

The CHMP also adopted a positive opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer), after re-examining its negative opinion adopted in July 2018.

For more information on these positive opinions following re-examination please see the question-and-answer documents in the grid below.

Outcome of review on quinolone and fluoroquinolone antibiotics

The CHMP recommended suspending some quinolone and fluoroquinolone antibiotics and introducing changes including restrictions on the use of all others following a review of disabling and potentially permanent side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on these medicines in June 2018. For more information, please see the public health recommendation in the grid below.

Withdrawal of extension of indication application

The application to extend the use of Tecentriq (atezolizumab) to treat kidney cancer was withdrawn. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the November 2018 meeting is published on EMA's website. Minutes of the October 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2018 CHMP meeting are represented in the graphic below.

 November 2018

Positive recommendations on new medicines

Name of medicine Erleada
INN apalutamide
Marketing-authorisation applicant Janssen-Cilag International N.V.
Therapeutic indication Treatment of non-metastatic castration resistant prostate cancer

 

Name of medicine Macimorelin Aeterna Zentaris
INN macimorelin
Marketing-authorisation applicant Aeterna Zentaris GmbH
Therapeutic indication Diagnosis of growth hormone deficiency in adults

Positive recommendation on new generic medicine

Name of medicine Silodosin Recordati
INN silodosin
Marketing-authorisation applicant Recordati Ireland Ltd
Therapeutic indication Treatment of the signs and symptoms of benign prostatic hyperplasia

Positive recommendation on medicine for use outside the European Union

Name of medicine Fexinidazole Winthrop
INN fexinidazole
Opinion holder sanofi-aventis groupe
Therapeutic indication Treatment of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense
More information Press release: CHMP recommends first oral-only treatment for sleeping sickness

Positive recommendations on extensions of indications

Name of medicine Kisqali
INN ribociclib
Marketing-authorisation applicant

Novartis Europharm Limited

 

Name of medicine Mabthera
INN rituximab
Marketing-authorisation applicant Roche Registration GmbH

 

Name of medicine Orkambi
INN lumacaftor / ivacaftor
Marketing-authorisation applicant Vertex Pharmaceuticals (Europe) Ltd

 

Name of medicine Ravicti
INN glycerol phenylbutyrate
Marketing-authorisation applicant Horizon Pharma Ireland Limited

Positive recommendations on extensions of indications following re-examination

Name of medicine Blincyto
INN blinatumomab
Marketing-authorisation applicant Amgen Europe B.V.

 

Name of medicine Opdivo
INN nivolumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG

 

Name of medicine Yervoy
INN ipilimumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG

Public-health recommendation

Name of medicine Quinolone- and fluoroquinolone-containing medicinal products
INN nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin
More information Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics

Outcomes of arbitration procedures

Name of medicine Diclofenac sodium spray gel 4%
INN diclofenac

 

Name of medicine Diotop capsules
INN diclofenac / omeprazole

 

Withdrawal of extension of indication application

Name of medicine Tecentriq
INN atezolizumab
Marketing-authorisation applicant Roche Registration GmbH

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