Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016

  • Eleven medicines recommended for approval, including three medicines for cancer

London, UK (September 16, 2016) – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its September meeting. The CHMP recommended granting a conditional marketing authorisation for Lartruvo (olaratumab) for the treatment of adults with advanced soft tissue sarcoma. Lartruvo is to be used in combination with doxorubicin (a chemotherapy medicine) in patients with advanced soft tissue sarcoma for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin. Lartruvo was reviewed under EMA’s accelerated assessment mechanism and has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Ibrance (palbociclib) for the treatment of women with locally-advanced or metastatic breast cancer. Ibrance is to be used to treat breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)–negative. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Ninlaro (ixazomib) for the treatment of multiple myeloma. This follows a re-examination of the Committee’s earlier negative opinion. Ninlaro is a new medicine that is taken orally to treat multiple myeloma, and it has an orphan designation. Please see the questions-and-answers document in the grid below for more information on this opinion.

Glyxambi (empagliflozin / linagliptin) was recommended for approval for the treatment of type 2 diabetes.

Parsabiv (etelcalcetide) was recommended for approval for the treatment of secondary hyperparathyroidism.

The Committee recommended granting a marketing authorisation for the orphan medicine SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours.

One hybrid application, Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid), received a positive opinion from the CHMP for the treatment of cerebrotendinous xanthomatosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. This medicine has an orphan designation.

Four generic medicines were recommended for approval by the Committee: Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine / Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil) to treat HIV infection and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension.

Two recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for NovoRapid and Stelara.

Outcome of review of compliance with good manufacturing practice (GMP) at Pharmaceutics International
The CHMP recommended that medicines manufactured by Pharmaceutics International Inc., located in the United States, should no longer be available in the European Union, except Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health. The recommendation is the outcome of a review into issues with GMP at Pharmaceutics International Inc. For more information, please see the public health communication in the grid below.

Withdrawals of applications

The application for a marketing authorisation for Cokiera (dasabuvir / ombitasvir / paritaprevir / ritonavir) has been withdrawn. Cokiera was intended for the treatment of chronic hepatitis C. A questions-and-answers document on this withdrawal is available below.

A request to extend the indication of Adempas (riociguat) to the treatment of pulmonary arterial hypertension has also been withdrawn. A questions-and-answers document on this withdrawal is available below.

Agenda and minutes

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

CHMP statistics

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

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

EMA

  • * Mysildecard (sildenafil), a generic of Revatio, received a positive opinion from the CHMP by written procedure in July 2016. This is reflected in the total number of positive opinions on new medicines for 2016.
  • ** Ninlaro received a positive opinion at the September CHMP following a re-examination. Therefore the number of negative opinions for 2016 has been revised to 0.

Positive recommendations on new medicines

Name of medicine

Glyxambi

International non-proprietary name (INN)

empagliflozin / linagliptin

Marketing-authorisation applicant

Boehringer Ingelheim International GmbH

Therapeutic indication

Treatment of type 2 diabetes mellitus

More information

Summary of opinion for Glyxambi

Name of medicine

Ibrance

INN

palbociclib

Marketing-authorisation applicant

Pfizer Limited

Therapeutic indication

Treatment of locally advanced or metastatic breast cancer

More information

Summary of opinion for Ibrance

Press release: New treatment for breast cancer

Name of medicine

Lartruvo

INN

olaratumab

Marketing-authorisation applicant

Eli Lilly Nederland B.V.

Therapeutic indication

Treatment of soft tissue sarcoma

More information

Summary of opinion for Lartruvo

Press release: New treatment for patients with soft tissue sarcoma

Name of medicine

Ninlaro

INN

ixazomib

Marketing-authorisation applicant

Takeda Pharma A/S

Therapeutic indication

Treatment of multiple myeloma

More information

Summary of opinion for Ninlaro

Questions and answers on the positive opinion on the marketing authorisation for Ninlaro

Name of medicine

Parsabiv

INN

etelcalcetide

Marketing-authorisation applicant

Amgen Europe B.V.

Therapeutic indication

Treatment of secondary hyperparathyroidism

More information

Summary of opinion for Parsabiv

Name of medicine

SomaKit TOC

INN

edotreotide

Marketing-authorisation applicant

Advanced Accelerator Applications

Therapeutic indication

Diagnosis of gastro-entero-pancreatic neuroendocrine tumours

More information

Summary of opinion for SomaKit TOC

Positive recommendations on new generic medicines

Name of medicine

Emtricitabine/Tenofovir disoproxil Zentiva

INN

emtricitabine / tenofovir disoproxil

Marketing-authorisation applicant

Zentiva k.s.

Therapeutic indication

Treatment of HIV infection

More information

Summary of opinion for Emtricitabine/Tenofovir disoproxil Zentiva

Name of medicine

Granpidam

INN

sildenafil

Marketing-authorisation applicant

Accord Healthcare Ltd

Therapeutic indication

Treatment of pulmonary arterial hypertension

More information

Summary of opinion for Granpidam

Name of medicine

Ivabradine JensonR

INN

ivabradine

Marketing-authorisation applicant

JensonR+Limited

Therapeutic indication

Treatment of angina pectoris and heart failure

More information

Summary of opinion for Ivabradine JensonR

Name of medicine

Ivabradine Zentiva

INN

ivabradine

Marketing-authorisation applicant

Zentiva, k.s.

Therapeutic indication

Treatment of angina pectoris and heart failure

More information

Summary of opinion for Ivabradine Zentiva


Positive recommendation on a new hybrid medicine

Name of medicine

Chenodeoxycholic acid sigma-tau

INN

chenodeoxycholic acid

Marketing-authorisation applicant

Sigma-tau Arzneimittel GmbH

Therapeutic indication

Treatment of cerebrotendinous xanthomatosis

More information

Summary of opinion for Chenodeoxycholic acid sigma-tau


Positive recommendations on extensions of therapeutic indications

Name of medicine

NovoRapid

INN

insulin aspart

Marketing-authorisation holder

Novo Nordisk A/S

More information

Summary of opinion for NovoRapid

Name of medicine

Stelara

INN

ustekinumab

Marketing-authorisation holder

Janssen-Cilag International NV

More information

Summary of opinion for Stelara


Public-health recommendation

Name of the procedure

Pharmaceutics International Inc

More information

Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings

Outcome of harmonisation procedure

Name of medicine

Clenil and associated names

INN

Beclometasone dipropionate

Marketing-authorisation holder

Chiesi and associated companies

More information

Questions and answers on Clenil and associated names


Withdrawals of application

Name of medicine

Adempas

INN

riociguat

More information

Questions and answers on the withdrawal of the marketing authorisation application for Adempas

Name of medicine

Cokiera

INN

dasabuvir / ombitasvir / paritaprevir / ritonavir

More information

Questions and answers on the withdrawal of the marketing authorisation application for Cokiera

Other opinion

Name of medicine

Abilify

INN

aripiprazole

More information

Questions and answers on the application to extend use of Abilify in schizophrenia to 13 and 14 year olds


Other updates

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Recommendations on eligibility to PRIME scheme
  • Opinions on safety variations
  • Guidelines and concept papers adopted
  • Organisational matters


European Medicines Agency (EMA), 16.06.2016 (tB).

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