Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018

News 21/09/2018

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) elected Harald Enzmann as its new chair at its September 2018 meeting, for a three-year mandate starting on 21 September.

This week's meeting of the CHMP was the last plenary meeting chaired by Dr Tomas Salmonson, who retires as chair after serving for two three-year mandates, the maximum allowed by the legislation. Dr Salmonson is a senior scientific advisor at the Swedish Medical Products Agency, where he has worked since 1986. He has been a member of the CHMP for more than 18 years and has served as chair of the Committee since September 2012.

EMA would like to thank Dr Salmonson for his outstanding contribution to the work of the CHMP, which has enabled progress in key areas of public health. In 2016, he was closely involved in the launch of the PRIority MEdicines scheme (PRIME), which supports the development of promising new medicines in the European Union (EU). Under his leadership, the Committee improved its benefit-risk methodologies considering new scientific developments and technological advances and it broke new ground in its engagement with key stakeholders, such as international regulators, health technology assessment bodies and patients, who have started to participate in the Committee's decision-making on medicines. Over the six years at the helm of the CHMP, he has promoted EMA and the EU regulatory system as a whole as a hub of excellence for medicines regulation for the benefit of public health in the EU and around the world.

Thirteen medicines recommended for approval, including three orphans

The CHMP recommended thirteen medicines for approval, including three orphan medicines1.

The Committee recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children with inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness. Luxturna was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. For more information, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for a new antibiotic, Vabomere (meropenem trihydrate / vaborbactam), for the treatment of various severe infections in adults. The development of new and effective antibiotics is one of the most powerful tools to fight antimicrobial resistance. For more information, please see the press release in the grid below.

Two more orphan medicines received a positive opinion from the Committee: Jivi (damoctocog alfa pegol), for the treatment of haemophilia A (congenital factor VIII deficiency), and Poteligeo (mogamulizumab), for the treatment of mycosis fungoides or Sézary syndrome.

The CHMP recommended granting marketing authorisations for two cancer medicines: Alunbrig (brigatinib), for the treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, and Apealea (paclitaxel), for the treatment of ovarian cancer.

Delstrigo (doravirine / lamivudine / tenofovir disoproxil) and Pifeltro (doravirine) received positive opinions for the treatment of HIV-1 infection.

Three biosimilar medicines intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy received a positive opinion from the Committee: Fulphila (pegfilgrastim), Pelmeg (pegfilgrastim) and Ziextenzo (pegfilgrastim).

The CHMP granted a positive opinion for Buvidal (buprenorphine), a hybrid medicine for the treatment of opioid dependence. 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.

Negative recommendation on a new medicine following re-examination

The applicant for Exondys (eteplirsen) requested a re-examination of the Committee's negative opinion for this medicine adopted at the May 2018 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine.

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

Seven recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Cabometyx, Elebrato Ellipta, Gilenya, RoActemra, Trelegy Ellipta, Venclyxto and Xtandi.

Start of re-examination of recommendations on extension of therapeutic indication

The applicants for Blincyto (blinatumomab), Opdivo (nivolumab) and Yervoy (ipilimumab) have requested re-examination of the Committee's negative opinions for these medicines adopted at the July 2018 meeting. The CHMP will now re-examine the opinions and issue final recommendations.

For more information on these negative opinions, please see the question-and-answer documents in the grid below.

Update on valsartan review

The CHMP is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other 'sartans', namely, candesartan, irbesartan, losartan and olmesartan. For more information, please see the public health communication in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Entolimod TMC (entolimod) and Treprostinil SciPharm Sàrl (treprostinil) have been withdrawn. Entolimod TMC was intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation. Treprostinil SciPharm Sàrl was intended to be used to treat chronic thromboembolic pulmonary hypertension.

Questions-and-answers documents on these withdrawals are available in the grid below.

Agenda and minutes

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

CHMP statistics

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


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.

PDF iconDownload image in pdf format

 

Positive recommendations on new medicines

Name of medicine Alunbrig
International non-proprietary name (INN) brigatinib
Marketing-authorisation applicant Takeda Pharma A/S
Therapeutic indication Treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib
More information PDF iconSummary of opinion for Alunbrig

 

Name of medicine Apealea
INN paclitaxel
Marketing-authorisation applicant Oasmia Pharmaceutical AB
Therapeutic indication Treatment of ovarian cancer
More information PDF iconSummary of opinion for Apealea

 

Name of medicine Delstrigo
INN doravirine / lamivudine / tenofovir disoproxil
Marketing-authorisation applicant Merck Sharp & Dohme B.V.
Therapeutic indication Treatment of HIV-1 infection
More information PDF iconSummary of opinion for Delstrigo

 

Name of medicine Emgality
INN galcanezumab
Marketing-authorisation applicant Eli Lilly Nederland B.V.
Therapeutic indication Prophylaxis of migraine
More information

PDF iconSummary of opinion for Emgality

 

Press release: New medicine for the prevention of migraine

 

Name of medicine Jivi
INN damoctocog alfa pegol
Marketing-authorisation applicant Bayer AG
Therapeutic indication Treatment of haemophilia A (congenital factor VIII deficiency)
More information PDF iconSummary of opinion for Jivi

 

Name of medicine Luxturna
INN voretigene neparvovec
Marketing-authorisation applicant Spark Therapeutics Ireland Ltd
Therapeutic indication Treatment of retinal dystrophies caused by RPE65 mutations
More information

PDF iconSummary of opinion for Luxturna

 

Press release: New gene therapy for rare inherited disorder causing vision loss recommended for approval

 

Name of medicine Pifeltro
INN doravirine
Marketing-authorisation applicant Merck Sharp & Dohme B.V.
Therapeutic indication Treatment of HIV-1 infection
More information PDF iconSummary of opinion for Pifeltro

 

Name of medicine Poteligeo
INN mogamulizumab
Marketing-authorisation applicant Kyowa Kirin Limited
Therapeutic indication Treatment of mycosis fungoides or Sézary syndrome
More information PDF iconSummary of opinion for Poteligeo

 

Name of medicine Vabomere
INN meropenem / vaborbactam
Marketing-authorisation applicant Rempex London Ltd
Therapeutic indication

Vabomere is indicated for the treatment of the following infections in adults:

  • Complicated urinary tract infection (cUTI), including pyelonephritis
  • Complicated intra-abdominal infection (cIAI)
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vabomere is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

More information

PDF iconSummary of opinion for Vabomere

 

Press release: New medicine to treat infections in adults

 

Positive recommendations on new biosimilar medicines

Name of medicine Fulphila
INN pegfilgrastim
Marketing-authorisation applicant MYLAN S.A.S
Therapeutic indication To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
More information PDF iconSummary of opinion for Fulphila

 

Name of medicine Pelmeg
INN pegfilgrastim
Marketing-authorisation applicant Cinfa Biotech S.L.
Therapeutic indication To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
More information PDF iconSummary of opinion for Pelmeg

 

Name of medicine Ziextenzo
INN pegfilgrastim
Marketing-authorisation applicant Sandoz GmbH
Therapeutic indication To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
More information PDF iconSummary of opinion for Ziextenzo

 

Positive recommendation on new hybrid medicine

Name of medicine Buvidal
INN buprenorphine
Marketing-authorisation applicant Camurus AB
Therapeutic indication Treatment of opioid dependence
More information PDF iconSummary of opinion for Buvidal

 

Negative recommendation for new medicine following re-examination

Name of medicine Exondys
INN eteplirsen
Marketing-authorisation applicant AVI Biopharma International Ltd.
Therapeutic indication Treatment of Duchenne muscular dystrophy
More information Questions and answers on Exondys

 

Positive recommendations on extensions of therapeutic indications

Name of medicine Cabometyx
INN cabozantinib
Marketing-authorisation holder Ipsen Pharma
More information PDF iconSummary of opinion for Cabometyx

 

Name of medicine Elebrato Ellipta
INN fluticasone furoate / umeclidinium / vilanterol fluticasone
Marketing-authorisation holder GlaxoSmithKline Trading Services Limited
More information PDF iconSummary of opinion for Elebrato Ellipta

 

Name of medicine Gilenya
INN fingolimod
Marketing-authorisation holder Novartis Europharm Limited
More information PDF iconSummary of opinion for Gilenya

 

Name of medicine RoActemra
INN tocilizumab
Marketing-authorisation holder Roche Registration GmbH
More information PDF iconSummary of opinion for RoActemra

 

Name of medicine Trelegy Ellipta
INN fluticasone furoate / umeclidinium / vilanterol fluticasone
Marketing-authorisation holder GlaxoSmithKline Trading Services Limited
More information PDF iconSummary of opinion for Trelegy Ellipta

 

Name of medicine Venclyxto
INN venetoclax
Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG
More information PDF iconSummary of opinion for Venclyxto

 

Name of medicine Xtandi
INN enzalutamide
Marketing-authorisation holder Astellas Pharma Europe B.V.
More information PDF iconSummary of opinion for Xtandi

 

Start of re-examination of recommendations on extensions of indications

Name of medicine Blincyto
INN blinatumomab
Marketing-authorisation applicant Amgen Europe B.V.
More information PDF iconQuestions and answers on Blincyto

 

Name of medicine Opdivo
INN nivolumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG
More information PDF iconQuestions and answers on Opdivo

 

Name of medicine Yervoy
INN ipilimumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG
More information PDF iconQuestions and answers on Yervoy

 

Update on valsartan review

Name of medicine Sartan medicines
INN valsartan, candesartan, irbesartan, losartan and olmesartan
Marketing-authorisation holder various companies
More information Valsartan: review of impurities extended to other sartan medicines

 

Withdrawal of initial marketing authorisation applications

Name of medicine Entolimod TMC
INN entolimod
Marketing-authorisation holder TMC Pharma Services Ltd
More information

PDF iconQuestions and answers on Entolimod TMC

 

Name of medicine Treprostinil SciPharm Sàrl
INN treprostinil
Marketing-authorisation holder SciPharm Sàrl
More information PDF iconQuestions and answers on Treprostinil SciPharm Sàrl

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 17-20 September 2018
PDF iconScientific advice and protocol assistance

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