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

News 24/06/2016

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 recommended for 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.

 June 2016

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Positive recommendations on new medicines

Name of medicineCinqaero
International non-proprietary name (INN)reslizumab
Marketing-authorisation applicantTeva Pharmaceuticals Limited
Therapeutic indicationTreatment of severe eosinophilic asthma
More information PDF iconSummary of opinion for Cinqaero

Name of medicineZalmoxis
INNallogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Marketing-authorisation applicantMolMed SpA
Therapeutic indicationTreatment in haploidentical haematopoietic stem cell transplantation
More information

PDF iconSummary of opinion for Zalmoxis

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 medicineAtazanavir Mylan
INNatazanavir
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of HIV-1 infection
More informationSummary of opinion for Atazanavir Mylan

Positive recommendations on new hybrid medicines

Name of medicineAerivio Spiromax
INNfluticasone propionate / salmeterol
Marketing-authorisation applicantTeva B.V.
Therapeutic indicationTreatment of asthma and COPD
More information PDF iconSummary of opinion for Aerivio Spiromax

Name of medicineAirexar Spiromax
INNfluticasone propionate / salmeterol
Marketing-authorisation applicantTeva B.V.
Therapeutic indicationTreatment of asthma and COPD
More information PDF iconSummary of opinion for Airexar Spiromax

Name of medicineNordimet
INNmethotrexate
Marketing-authorisation applicantNordic Group B.V.
Therapeutic indicationTreatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis
More information PDF iconSummary of opinion for Nordimet

Positive recommendations on extensions of therapeutic indications

Name of medicineCervarix
INNhuman papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Marketing-authorisation holderGlaxoSmithKline Biologicals
More information PDF iconSummary of opinion for Cervarix

Name of medicineIlaris
INNcanakinumab
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Ilaris

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Keytruda

Name of medicineNevanac
INNnepafenac
Marketing-authorisation holderAlcon Laboratories (UK) Ltd
More information PDF iconSummary of opinion for Nevanac

Name of medicineRoActemra
INNtocilizumab
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for RoActemra

Name of medicineRyzodeg
INNinsulin degludec / insulin aspart
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Ryzodeg

Name of medicineZontivity
INNvorapaxar
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Zontivity

Negative recommendation on extension of therapeutic indication

Name of medicineArzerra
INNofatumumab
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconQuestions and answers on refusal of a change to the marketing authorisation for Arzerra

Start of referral

Name of medicinePharmaceutics International Inc.
More informationStart of review of medicines manufactured at Pharmaceutics International Inc., USA

Public-health recommendations

Name of medicineAlkem Laboratories Limited
More informationStudies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU

Name of medicineAdempas
INNriociguat
Marketing-authorisation holderBayer Pharma AG
More informationAdempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia

Name of medicineNoxafil
INNposaconazole
Marketing-authorisation holderMerck Sharp & Dohme Ltd
More informationEMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable

Withdrawals of applications

Name of medicineAlendronic Acid/Colecalciferol Mylan
INNalendronic acid / colecalciferol
More information PDF iconQuestions and answers on Alendronic Acid/Colecalciferol Mylan

Name of medicineArikayce
INNamikacin
More information PDF iconQuestions and answers on Arikayce

Name of medicineDocetaxel SUN
INNdocetaxel
More information PDF iconQuestions and answers on Docetaxel SUN

Name of medicineKyndrisa
INNdrisapersen
More information PDF iconQuestions and answers on Kyndrisa

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconRecommendations on eligibility to PRIME scheme
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in June 2016 by the Name Review Group (NRG)
PDF iconOrganisational matters

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