EMA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016

 

  • Six medicines, including two orphan medicines, recommended for approval

 

London,  UK (February 26, 2016) – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorisation at its February 2016 meeting. The CHMP recommended granting marketing authorisations for two medicines for the prevention and treatment of bleeding in patients with haemophilia B, Alprolix (eftrenonacog alfa) and Idelvion (albutrepenonacog alfa). Both these medicines have an orphan designation.


Lonsurf (trifluridine / tipiracil) was recommended by the CHMP for the treatment of metastatic colorectal cancer.

Descovy (emtricitabine / tenofovir alafenamide) received a positive opinion for the treatment of HIV infection.

The CHMP recommended granting a marketing authorisation for Taltz (ixekizumab) for the treatment of plaque psoriasis.

The generic medicine Palonosetron Hospira (palonosetron) received a positive recommendation from the Committee for the prevention of nausea and vomiting associated with chemotherapy.

 

 

Seven recommendations on extensions of therapeutic indications

 

The Committee recommended extensions of indications for Giotrif, Humira, Ruconest, TachoSil, Zydelig and two extensions of indications for Opdivo. For more information on the extensions of indications for Opdivo, please see the press release in the grid below.

 

 

Start of review: medicines containing dienogest and ethinylestradiol

 

The CHMP started a review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg when used for acne. These products are available in several countries in the European Union (EU) as oral contraceptives and for the treatment of moderate acne in women. For more information, please refer to the start of referral document in the grid below.

 

 

Outcome of review on SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

 

The CHMP confirmed recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). For more information, please see the public health communication in the grid below.

 

 

CHMP confirms recommendations to minimise risk of the brain infection PML with Tysabri

 

EMA’s scientific review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) is now completed, with the CHMP confirming the PRAC recommendations aimed at minimising this risk. For more information, please see the public health communication in the grid below.

 

 

PRIME and early access tools

 

The CHMP adopted the final document on PRIME, a new scheme to support the development of medicines addressing unmet medical needs, as well as revised guidelines on the implementation of accelerated assessment and conditional marketing authorisation. These documents will be published on the EMA website in early March.

 

 

Agenda and minutes

 

The agenda of the February 2016 meeting is published on EMA’s website. Minutes of the January 2016 CHMP meeting will be published next week.

 

 

CHMP statistics

 

Key figures from the February 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s February 2016 meeting, is available in the grid below.

CHMP_highlights_February_2016.jpg

 

Download image in PDF format

 

 

Positive recommendations on new medicines

 

Name of medicine

Alprolix

INN

eftrenonacog alfa

Marketing-authorisation applicant

Biogen Idec Ltd

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B

More information

Summary of opinion for Alprolix

 

Name of medicine

Descovy

INN

emtricitabine / tenofovir alafenamide

Marketing-authorisation applicant

Gilead Sciences International Ltd

Therapeutic indication

Treatment of HIV infection

More information

Summary of opinion for Descovy

 

Name of medicine

Idelvion

INN

albutrepenonacog alfa

Marketing-authorisation applicant

CSL Behring GmbH

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B

More information

Summary of opinion for Idelvion

 

Name of medicine

Lonsurf

INN

trifluridine / tipiracil

Marketing-authorisation applicant

Les Laboratoires Servier

Therapeutic indication

Treatment of  metastatic colorectal cancer

More information

Summary of opinion for Lonsurf

 

Name of medicine

Taltz

INN

ixekizumab

Marketing-authorisation applicant

Eli Lilly Nederland B.V.

Therapeutic indication

Treatment of plaque psoriasis  

More information

Summary of opinion for Taltz

 

 

Positive recommendation on new generic medicine

 

Name of medicine

Palonosetron Hospira

INN

palonosetron

Marketing-authorisation applicant

Hospira UK Limited

Therapeutic indication

Prevention of nausea and vomiting associated with cancer chemotherapy

More information

Summary of opinion for Palonosetron Hospira

  

Positive recommendations on extensions of therapeutic indications

Name of medicine

Giotrif

INN

afatinib

Marketing-authorisation holder

Boehringer Ingelheim International GmbH

More information

Summary of opinion for Giotrif

  

Name of medicine

Humira

INN

adalimumab

Marketing-authorisation holder

AbbVie Ltd

More information

Summary of opinion for Humira

 

Name of medicine

Opdivo

INN

nivolumab

Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

More information

Summary of opinion for Opdivo

 

Press release: New treatment for advanced form of kidney cancer

 

Name of medicine

Ruconest

INN

conestat alfa

Marketing-authorisation holder

Pharming Group N.V

More information

Summary of opinion for Ruconest

 

Name of medicine

TachoSil

INN

human thrombin / human fibrinogen

Marketing-authorisation holder

Takeda Austria GmbH

More information

Summary of opinion for TachoSil

 

Name of medicine

Zydelig

INN

idelalisib

Marketing-authorisation holder

Gilead Sciences International Ltd

More information

Summary of opinion for Zydelig

 

 

Recommendation for new contraindication

 

Name of medicine

Telzir

INN

fosamprenavir

Marketing-authorisation holder

ViiV Healthcare UK Limited

More information

Summary of opinion for Telzir

 

 

Start of referral

 

Name of medicine

Dienogest / Ethinylestradiol containing medicinal products indicated in acne

INN

dienogest / ethinylestradiol

More information

Start of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne

 

 

Public health recommendations

 

Name of medicine

Tysabri 

INN

natalizumab

Marketing-authorisation holder

Biogen Idec Ltd

More information

EMA confirms recommendations to minimise risk of brain infection PML with Tysabri

 

Name of medicine

SGLT2 inhibitors 

INN

canagliflozin, dapagliflozin, empagliflozin

Marketing-authorisation holder

AstraZeneca AB (Forxiga, Xigduo), Boehringer Ingelheim International GmbH (Jardiance, Synjardy), Janssen-Cilag International N.V. (Invokana, Vokanamet)

More information

EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes

 

 

Outcome of harmonisation procedure

 

Name of medicine

 Cymevene

INN

ganciclovir

Marketing-authorisation holder

F. Hoffmann-La Roche

More information

Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous

 

 

Other updates

 

 


 

European Medicines Agency, 26.02.2016 (tB) Thomas Backe

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