Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018

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26/01/2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018

Seven medicines recommended for approval, including one orphan

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine1, at its January 2018 meeting.

The CHMP recommended granting a marketing authorisation for Hemlibra (emicizumab), a first-in-class medicine to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Lamzede (velmanase alfa), a long-term enzyme replacement therapy in adults, adolescents and children with mild to moderate forms of alpha-mannosidosis. Because alpha-mannosidosis is a very rare disease, Lamzede was granted an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Shingrix (recombinant, adjuvanted Herpes zoster vaccine), a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older.

The CHMP gave positive opinions for three medicines to treat type 2 diabetes: Segluromet (ertugliflozin / metformin), Steglatro (ertugliflozin) and Steglujan (ertugliflozin / sitagliptin).

One biosimilar medicine was recommended for approval by the Committee: Semglee (insulin glargine), for the treatment of diabetes.

Re-adoption of opinion on new medicine

The CHMP confirmed its previous positive opinion and recommended the granting of a marketing authorisation for Lokelma (sodium zirconium cyclosilicate), for the treatment of hyperkalaemia.

Lokelma had received a positive opinion in February 2017. However, the European Commisson suspended its decision-making following some concerns relating to good manufacturing practices (GMP) at the manufacturing site for the active substance and referred the matter back to the CHMP. A new inspection of the manufacturing site for Lokelma’s active substance showed that the site is compliant with GMP. On the basis of the inspection findings, the Committee confirmed its previous opinion.

Negative opinion on new medicine

The CHMP adopted a negative opinion for EnCyzix (enclomifene). EnCyzix was expected to be used to treat hypogonadotrophic hypogonadism in men. For more information on this negative opinion, please see the questions-and-answers document in the grid below.

Start of re-examination of recommendation on new medicine

The applicant for Aplidin (plitidepsin) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the December 2017 meeting. The CHMP will now re-examine this opinion and issue a final recommendation.

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 Hizentra, Relvar Ellipta and Revinty Ellipta.

Negative recommendation on extension of indication following re-examination

The applicant for Raxone (idebenone) requested a re-examination of the Committee’s negative opinion for this medicine adopted at the September 2017 meeting. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the change to the marketing authorisation.

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

Withdrawals of applications

Applications for initial marketing authorisations for Balimek (binimetinib) and Rotigotine Mylan (rotigotine) have been withdrawn. Balimek was intended to be used to treat melanoma (a type of skin cancer) that had spread or could not be removed by surgery. Rotigotine Mylan was intended to be used to treat Parkinson’s disease and restless-leg syndrome.

An application to extend the use of Opdivo (nivolumab) to treat colorectal cancer has also been withdrawn.

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

Agenda and minutes

The agenda of the January 2018 meeting is published on EMA’s website. Minutes of the December 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

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

More information on all other outcomes of the CHMP January 2018 meeting is available in the grid below.


1As always at time of approval, this orphan designation will now be reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.

 

CHMP_highlights_January_2018

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Positive recommendations on new medicines

Name of medicineHemlibra 
International non-proprietary name (INN)emicizumab
Marketing-authorisation applicantRoche Registration Limited
Therapeutic indicationPrevention of bleeding episodes in patients with haemophilia A who have factor VIII inhibitors
More information

Summary of opinion for Hemlibra

 

Press release: First-in-class medicine to prevent bleeding in haemophilia A patients with inhibitors

 

Name of medicine Lamzede
INNvelmanase alfa
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationTreatment of patients with non-neurological manifestations of mild to moderate alpha-mannosidosis
More information

Summary of opinion for Lamzede

 

Press release: New enzyme replacement therapy to treat rare genetic disorder alpha-mannosidosis in children and adults

  

Name of medicineSegluromet
INNertugliflozin / metformin
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of type 2 diabetes
More informationSummary of opinion for Segluromet

 

Name of medicineShingrix
Common nameherpes zoster vaccine (recombinant, adjuvanted)
Marketing-authorisation applicantGlaxoSmithkline Biologicals SA
Therapeutic indicationPrevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older
More informationSummary of opinion for Shingrix

 

Name of medicineSteglatro
INNertugliflozin
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of type 2 diabetes
More informationSummary of opinion for Steglatro

 

Name of medicineSteglujan
INNertugliflozin / sitagliptin
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of type 2 diabetes
More informationSummary of opinion for Steglujan

 

Positive recommendation on new biosimilar medicine

Name of medicineSemglee 
INNinsulin glargine
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of diabetes
More informationSummary of opinion for Semglee

 

Re-adoption of opinion for new medicine

Name of medicine Lokelma
INNsodium zirconium cyclosilicate
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of hyperkalaemia
More informationSummary of opinion for Lokelma

 

Negative recommendation for new medicine

Name of medicineEnCyzix
INNenclomifene
Marketing-authorisation applicantRenable Pharma Limited
Therapeutic indicationTreatment of hypogonadotropic hypogonadism in men
More informationQuestions and answers on EnCyzix

 

Start of re-examination of recommendation on new medicine

Name of medicineAplidin
INNplitidepsin
Marketing-authorisation applicantPharma Mar
Therapeutic indicationTreatment of multiple myeloma
More informationQuestions and answers on Aplidin

  

Positive recommendations on extensions of indications

Name of medicineHizentra
INNhuman normal immunoglobulin
Marketing-authorisation holderCSL Behring GmbH
More informationSummary of opinion for Hizentra

    

Name of medicineRelvar Ellipta
INNfluticasone furoate / vilanterol
Marketing-authorisation holderGlaxo Group Ltd
More informationSummary of opinion for Relvar Ellipta

 

Name of medicineRevinty Ellipta
INNfluticasone furoate / vilanterol
Marketing-authorisation holderGlaxo Group Ltd
More informationSummary of opinion for Revinty Ellipta

 

Negative recommendation on extension of indication following re-examination

Name of medicineRaxone
INNidebenone
Marketing-authorisation holderSanthera Pharmaceuticals (Deutschland) GmbH
More informationQuestions and answers on Raxone

 

Withdrawals of initial marketing autorisation applications

Name of medicineBalimek
INNbinimetinib
Marketing-authorisation applicantPierre Fabre Médicament
More informationQuestions and answers on Balimek

 

Name of medicineRotigotine Mylan
INNrotigotine
Marketing-authorisation applicantMylan S.A.S
More informationQuestions and answers on Rotigotine Mylan

 

Withdrawal of extension of indication application

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationQuestions and answers on Opdivo

 

Other updates

Recommendations on eligibility to PRIME scheme
Scientific advice and protocol assistance
Overview of (invented) names reviewed in December 2017 by the Name Review Group (NRG)

 

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