Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting.

Two orphan medicines¹ received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.

The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

Rizmoic (naldemedine) received a positive opinion for the treatment of opioid-induced constipation.

The Committee granted a positive opinion for Tobramycin PARI (tobramycin), a hybrid medicine for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.

The biosimilar medicine Zirabev (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.

The Committee recommended for approval the generic medicine Miglustat Dipharma (miglustat), for the treatment of adult patients with mild to moderate type 1 Gaucher disease.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Adcetris, Rapiscan, Rubraca, Simponi, Sprycel and Trimbow.

Start of referral

The CHMP started a review of medicines containing the antibiotic fosfomycin, which is used in a number of EU Member States to treat a range of bacterial infections. The Committee will re-evaluate the uses and doses authorised in the light of up-to-date knowledge on antibacterial therapy. For more information, please see the start-of-referral document in the grid below.

Outcome of review on metamizole-containing medicines

The CHMP recommended that the maximum daily dose of the painkiller metamizole and the contraindications to its use in pregnancy or in women who are breastfeeding should be harmonised for all products on the EU market. Metamizole medicines are marketed in many EU Member States to treat severe pain and fever that cannot be controlled with other treatments. For more information, please see the public health recommendation in the grid below.

Outcome of review on omega-3 fatty acid medicines

The CHMP concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use. For more information, please see the public health recommendation in the grid below.

Status of review of impurities in sartan medicines

The review of the blood pressure medicines containing candesartan, irbesartan, losartan, olmesartan or valsartan in relation to impurities found in some batches is still ongoing. A new timetable for the finalisation of the review will be published shortly.

Withdrawals of applications

Applications for initial marketing authorisations for Fyzoclad (adalimumab) and canakinumabNovartis (canakinumab) have been withdrawn. Fyzoclad was intended to be used to treat a number of inflammatory diseases. Canakinumab Novartis was intended to be used to prevent serious events such as stroke, heart attack or death in patients who have had a heart attack.

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

Agenda and minutes

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

¹ As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines’ orphan status and granting the medicines ten years of market exclusivity.

CHMP statistics

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

Positive recommendations on new medicines

Name of medicine	Besremi
International non-proprietary name (INN)	ropeginterferon alfa-2b
Marketing-authorisation applicant	AOP Orphan Pharmaceuticals AG
Therapeutic indication	Treatment of polycythaemia vera without symptomatic splenomegaly.

CHMP summary of positive opinion for Besremi

AdoptedReference Number: EMA/CHMP/867687/2018

English (EN) (67.87 KB - PDF)

First published: 14/12/2018

Name of medicine	Trecondi
INN	treosulfan
Marketing-authorisation applicant	medac Gesellschaft fur klinische Spezialpraparate mbH
Therapeutic indication	Conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT)

Name of medicine	Adcetris
INN	brentuximab vedotin
Marketing-authorisation holder	Takeda Pharma A/S

Name of medicine	Rapiscan
INN	regadenoson
Marketing-authorisation holder	GE Healthcare AS

Name of medicine	Rubraca
INN	rucaparib
Marketing-authorisation holder	Clovis Oncology UK Limited

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Positive recommendations on new medicines

Positive recommendation on new hybrid medicine

Positive recommendation on new biosimilar medicine

Positive recommendations on new generic medicine

Positive recommendations on extensions of indications

Start of referral

Public-health recommendations

Withdrawal of initial marketing authorisation applications

Other updates

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