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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021

News 23/04/2021

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2021 meeting.

The Committee gave a positive opinion for Enspryng* (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. See more details in the news announcement in the grid below.

Evkeeza (evinacumab) was granted a positive opinion by the Committee for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza was reviewed under EMA’s accelerated assessment programme.

The Committee recommended granting a marketing authorisation for Adtralza (tralokinumab) for the treatment of adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Koselugo* (selumetinib) was granted a positive opinion for the treatment of paediatric patients with neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN).

The Committee adopted a positive opinion for Onureg (azacitidine) for the maintenance treatment of patients with acute myeloid leukemia.

The CHMP recommended granting marketing authorisations for two generic medicines: Abiraterone Krka (abiraterone acetate) for the treatment of adult men with metastatic prostate cancer and Celsunax (ioflupane (123I)) intended for detecting loss of functional dopaminergic neuron terminals in the striatum.

The Committee recommended granting a marketing authorisation for the hybrid medicine Jayempi (azathioprine) intended for prophylaxis against transplant rejection and as immunosuppressive antimetabolite either alone or in combination with other agents to influence the immune response in a variety of diseases. Hybrid applications rely in part on the results of pre-clinical tests and?clinical trials?of an already authorised reference product and in part on new data.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication?for Aubagio, BiResp Spiromax, DuoResp Spiromax, Maviret, Nulojix, Opdivo, Tagrisso, Venclyxto and Yervoy.

Agenda and minutes

The agenda of the April 2021 CHMP meeting is published on EMA's website. Minutes of the March 2021?CHMP?meeting will be published in the coming weeks.

CHMP statistics

Key figures from the April 2021?CHMP?meeting are represented in the graphic below.

CHMP April 2021


*This product was designated as an?orphan medicine?during its development.?Orphan designations?are reviewed by EMA's?Committee for Orphan Medicinal Products?(COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of?market exclusivity.

Positive recommendations on new medicines

Name of medicineAdtralza
International non-proprietary name?(INN)tralokinumab
Marketing-authorisation applicantLeo Pharma A/S
Therapeutic indicationTreatment of?moderate?to?severe atopic dermatitis
More informationAdtralza: Pending EC decision

?

Name of medicineEnspryng
INNsatralizumab
Marketing-authorisation applicantRoche Registration GmbH
Therapeutic indicationTreatment of neuromyelitis optica spectrum disorders (NMOSD)
More information

Enspryng: Pending EC decision

Press release:New treatment for rare autoimmune disease of nerve cells

?

Name of medicineEvkeeza
INNevinacumab
Marketing-authorisation applicantRegeneron Ireland Designated Activity Company (DAC)
Therapeutic indicationTreatment of adult and adolescent patients with homozygous familial hypercholesterolaemia (HoFH)
More informationEvkeeza: Pending EC decision

?

Name of medicineKoselugo
INNselumetinib
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of paediatric patients with neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN)
More informationKoselugo: Pending EC decision

?

Name of medicineOnureg
INNazacitidine
Marketing-authorisation applicantCelgene Europe BV
Therapeutic indicationMaintenance treatment of patients with acute myeloid leukemia
More informationOnureg: Pending EC decision

?

Positive recommendations on new generic medicines

Name of medicineAbiraterone Krka
International non-proprietary name?(INN)abiraterone acetate
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of metastatic prostate cancer
More informationAbiraterone Krka: Pending EC decision

?

Name of medicineCelsunax
INNioflupane (123I)
Marketing-authorisation applicantPinax Pharma GmbH
Therapeutic indicationDetecting loss of functional dopaminergic neuron terminals in the striatum
More informationCelsunax: Pending EC decision

?

Positive recommendation on new hybrid medicine

Name of medicineJayempi
INNazathioprine
Marketing-authorisation applicantNova Laboratories Ireland Limited
Therapeutic indicationProphylaxis against transplant rejection and as immunosuppressive antimetabolite
More informationJayempi: Pending EC decision

?

Positive recommendations on extensions of indication

Name of medicineAubagio
INNteriflunomide
Marketing-authorisation holderSanofi-Aventis Groupe
More informationAubagio: Pending EC decision

?

Name of medicineBiResp Spiromax
INNbudesonide / formoterol
Marketing-authorisation holderTeva Pharma B.V.
More informationBiResp Spiromax: Pending EC decision

?

Name of medicineDuoResp Spiromax
INNbudesonide / formoterol
Marketing-authorisation holderTeva Pharma B.V.
More informationDuoResp Spiromax: Pending EC decision

?

Name of medicineMaviret
INNglecaprevir / pibrentasvir
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More informationMaviret: Pending EC decision

?

Name of medicineNulojix
INNbelatacept
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationNulojix: Pending EC decision

?

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationOpdivo: Pending EC decision

?

Name of medicineTagrisso
INNosimertinib
Marketing-authorisation holder

AstraZeneca AB

More informationTagrisso: Pending EC decision

?

Name of medicineVenclyxto
INNvenetoclax
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More informationVenclyxto: Pending EC decision

?

Name of medicineYervoy
INNipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationYervoy: Pending EC decision

?

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