Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016

Six new medicines, including one cell-based therapy, recommended for approval

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including one advanced therapy medicinal product (ATMP), for approval at its June meeting.

The CHMP recommended granting a conditional marketing authorisation for the ATMP Zalmoxis as an adjunctive, or add-on, treatment for adult patients receiving a haploidentical haematopoietic stem cell transplant (HSCT) for types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease. Zalmoxis has an orphan designation. For more information, please see the press release in the grid below.

The Committee also recommended granting a marketing authorisation for Cinqaero (reslizumab) as an add-on treatment for adult patients with severe eosinophilic asthma.

The generic medicine Atazanavir Mylan (atazanavir) was recommended by the CHMP for the treatment of human immunodeficiency virus-1 (HIV-1) infections.

Three hybrid applications received positive recommendations from the Committee. Aerivio Spiromax and Airexar Spiromax, both containing salmeterol xinafoate and fluticasone propionate, were recommendedfor the treatment of asthma and chronic obstructive pulmonary disorder (COPD). Nordimet (methotrexate) was recommended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis. 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.

Request for re-examination of CHMP recommendation

The applicant for Ninlaro has requested a re-examination of the CHMP's negative opinion for this medicine adopted at the May 2016 meeting. Upon receipt of the grounds for re-examination, the CHMP will re-examine this opinion and issue a final opinion.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Cervarix, Ilaris, Keytruda, Nevanac, RoActemra, Ryzodeg and Zontivity.

Negative opinion on extension of indication

The CHMP adopted a negative opinion on the request for an extension of therapeutic indication for Arzerra. A questions and answers document is available in the grid below.

Start of review: Pharmaceutics International Inc

The CHMP started a review of medicines manufactured by Pharmaceutics International Inc, USA. This follows an inspection in February 2016 which highlighted several shortcomings in relation to good manufacturing practice (GMP). For more information, please see the start of referral document in the grid below.

Outcome of Alkem Laboratories Ltd review

The CHMP recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU. The recommendations follow a joint routine inspection by German and Dutch authorities in March 2015. For more information, please see the public health communication in the grid below.

Review of a safety signal for Adempas

The Committee recommended that Adempas (riociguat) should not be used in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia or PH-IIP (high blood pressure in lung arteries caused by a lung disease called idiopathic interstitial pneumonia). These recommendations have been issued in the context of a review of a safety signal. For more information, please see the public health communication in the grid below.

Update to product information for Noxafil

The CHMP has warned that Noxafil (posaconazole) tablets and oral suspension have different doses and are not interchangeable. The product information for the medicine is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose. For more information, please see the public health communication in the grid below.

Withdrawals of applications

Applications for marketing authorisations for Alendronic Acid/Colecalciferol Mylan (alendronic acid/colecalciferol), Arikayce (amikacin), Docetaxel Sun (docetaxel) and Kyndrisa (drisapersen) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the June 2016 meeting is published on EMA's website. Minutes of the May 2016 CHMP meeting will be published next week.

CHMP statistics

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

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

CHMP statistics: June 2016

Positive recommendations on new medicines

Name of medicine	Cinqaero
International non-proprietary name (INN)	reslizumab
Marketing-authorisation applicant	Teva Pharmaceuticals Limited
Therapeutic indication	Treatment of severe eosinophilic asthma
More information	CHMP summary of positive opinion for Cinqaero

Name of medicine	Zalmoxis
INN	allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Marketing-authorisation applicant	MolMed SpA
Therapeutic indication	Treatment in haploidentical haematopoietic stem cell transplantation
More information	Press release: New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer

Positive recommendation on new generic medicine

Name of medicine	Atazanavir Mylan
INN	atazanavir
Marketing-authorisation applicant	Mylan S.A.S
Therapeutic indication	Treatment of HIV-1 infection
More information

Positive recommendations on new hybrid medicines

Name of medicine	Aerivio Spiromax
INN	fluticasone propionate / salmeterol
Marketing-authorisation applicant	Teva B.V.
Therapeutic indication	Treatment of asthma and COPD
More information

Name of medicine	Airexar Spiromax
INN	fluticasone propionate / salmeterol
Marketing-authorisation applicant	Teva B.V.
Therapeutic indication	Treatment of asthma and COPD
More information

Name of medicine	Nordimet
INN	methotrexate
Marketing-authorisation applicant	Nordic Group B.V.
Therapeutic indication	Treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis
More information	CHMP summary of opinion for Nordimet

Positive recommendations on extensions of therapeutic indications

Name of medicine	Cervarix
INN	human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Marketing-authorisation holder	GlaxoSmithKline Biologicals
More information	CHMP post-authorisation summary of positive opinion for Cervarix

Name of medicine	Ilaris
INN	canakinumab
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Ilaris

Name of medicine	Keytruda
INN	pembrolizumab
Marketing-authorisation holder	Merck Sharp & Dohme Limited
More information	CHMP post-authorisation summary of positive opinion for Keytruda

Name of medicine	Nevanac
INN	nepafenac
Marketing-authorisation holder	Alcon Laboratories (UK) Ltd
More information	CHMP post-authorisation summary of positive opinion for Nevanac

Name of medicine	RoActemra
INN	tocilizumab
Marketing-authorisation holder	Roche Registration Limited
More information	CHMP post-authorisation summary of positive opinion for RoActemra (II/57)

Name of medicine	Ryzodeg
INN	insulin degludec / insulin aspart
Marketing-authorisation holder	Novo Nordisk A/S
More information	CHMP post-authorisation summary of positive opinion for Ryzodeg

Name of medicine	Zontivity
INN	vorapaxar
Marketing-authorisation holder	Merck Sharp & Dohme Limited
More information	CHMP post-authorisation summary of positive opinion for Zontivity (II/0005)

Negative recommendation on extension of therapeutic indication

Name of medicine	Arzerra
INN	ofatumumab
Marketing-authorisation holder	Novartis Europharm Ltd
More information

Start of referral

Name of medicine	Pharmaceutics International Inc.
More information	Start of review of medicines manufactured at Pharmaceutics International Inc., USA

Public-health recommendations

Name of medicine	Alkem Laboratories Limited
More information	Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU

Name of medicine	Adempas
INN	riociguat
Marketing-authorisation holder	Bayer Pharma AG
More information	Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia

Name of medicine	Noxafil
INN	posaconazole
Marketing-authorisation holder	Merck Sharp & Dohme Ltd
More information	EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable

Withdrawals of applications

Name of medicine	Alendronic Acid/Colecalciferol Mylan
INN	alendronic acid / colecalciferol
More information	Questions and answers on the withdrawal of the marketing authorisation application for Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol)