Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017

News 15/12/2017

Seven medicines recommended for approval, including an advanced therapy

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval at its December 2017 meeting, including two orphan medicines1, one of which is also an advanced therapy medicinal product (ATMP).

The CHMP recommended granting a marketing authorisation for the ATMP Alofisel (darvadstrocel), for the treatment of complex perianal fistulas in patients with Crohn's disease. Alofisel has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a paediatric-use marketing authorisation (PUMA) for Alkindi (hydrocortisone), for the treatment of primary adrenal insufficiency, a rare hormonal disorder in infants, children and adolescents. PUMAs can be granted for medicines which are already authorised but no longer under patent protection, and have been developed specifically for children. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Crysvita (burosumab), for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children and adolescents with growing skeletons. Crysvita has an orphan designation. For more information, please see the press release in the grid below.

Ozempic (semaglutide) received a positive opinion for the treatment of type 2 diabetes.

One biosimilar medicine was recommended for approval by the Committee: Herzuma (trastuzumab), for the treatment of breast and gastric cancer.

Two generic medicines received a positive opinion from the CHMP: Anagrelide Mylan (anagrelide), for the reduction of elevated platelet counts in at risk essential thrombocythaemia patients; and Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (efavirenz / emtricitabine / tenofovir disoproxil), for the treatment of HIV infection.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Aplidin (plitidepsin). Aplidin was expected to be used to treat multiple myeloma. For more information on this negative opinion, please see the questions-and-answers document in the grid below.

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Taltz, Truvada and Yervoy.

Outcome of review on mycophenolate

The CHMP concluded that current evidence does not indicate a risk of malformations or miscarriages during pregnancy when the father has taken mycophenolate medicines (used to prevent rejection of transplanted organs), although the risk of genotoxicity cannot be completely ruled out. For male patients, the CHMP now recommends that either the male patient or his female partner use reliable contraception (it is no longer required that they both use contraception). For female patients, the risk is unchanged.

For more information please see the public health communication in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for Qizenday (biotin) was withdrawn. This medicine was intended to be used for the treatment of progressive multiple sclerosis. A questions-and-answers document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the December 2017 meeting is published on EMA's website. Minutes of the November 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the December 2017 CHMP meeting are represented in the graphic below.

More information on all other outcomes of the CHMP December 2017 meeting is available in the grid below.


1As 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.

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Positive recommendations on new medicines

Name of medicineAlofisel
INNdarvadstrocel
Marketing-authorisation applicantTigenix, S.A.U.
Therapeutic indicationTreatment of complex perianal fistulas in patients with Crohn's disease
More information

PDF iconSummary of opinion for Alofisel

Press release: New medicine to treat perianal fistulas in patients with Crohn's disease

Name of medicineCrysvita
INNburosumab
Marketing-authorisation applicantKyowa Kirin Limited
Therapeutic indicationTreatment of X-linked hypophosphataemia
More information

PDF iconSummary of opinion for Crysvita

Press release: New medicine for rare bone disease

Name of medicineOzempic
INNsemaglutide
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of type 2 diabetes
More information PDF iconSummary of opinion for Ozempic

Positive recommendation on new biosimilar medicine

Name of medicineHerzuma
INNtrastuzumab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of breast and gastric cancer
More information PDF iconSummary of opinion for Herzuma

Positive recommendation on new hybrid medicine

Name of medicineAlkindi
International non-proprietary name (INN)hydrocortisone
Marketing-authorisation applicantDiurnal Ltd
Therapeutic indicationReplacement therapy of adrenal insufficiency in infants, children and adolescents
More information

PDF iconSummary of opinion for Alkindi

Press release: First paediatric medicine to treat rare hormonal disorder

Positive recommendation on new generic medicine

Name of medicineAnagrelide Mylan
INNanagrelide
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationReduction of elevated platelet counts in at risk essential thrombocythaemia patients
More information PDF iconSummary of opinion for Anagrelide Mylan

Name of medicineEfavirenz/Emtricitabine/Tenofovir disoproxil Krka
INNefavirenz / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Negative recommendation for new medicine

Name of medicineAplidin
INNplitidepsin
Marketing-authorisation applicantPharmaMar
Therapeutic indicationTreatment of multiple myeloma
More information PDF iconQuestions and answers on Aplidin (published on 20/12/2017)

Positive recommendations on extensions of indications

Name of medicineTaltz
INNixekizumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More information PDF iconSummary of opinion for Taltz

Name of medicineTruvada
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation holderGilead Sciences International Limited
More information PDF iconSummary of opinion for Truvada

Name of medicineYervoy
INNipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Yervoy

Public-health recommendation

Name of medicineMycophenolate
More informationMycophenolate: updated recommendations for contraception for men and women

Withdrawal of application

Name of medicineQizenday
INNbiotin
Marketing-authorisation applicantMedday Pharmaceuticals
More information PDF iconQuestions and answers on Qizenday

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
PDF iconOverview of (invented) names reviewed in November 2017 by the Name Review Group (NRG)

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