Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022

News 20/05/2022

Nine new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting.

A recommendation for marketing authorisation was adopted for Cevenfacta (eptacog beta (activated)) for the treatment of bleeding episodes in patients with congenital haemophilia.

The CHMP gave a positive opinion under exceptional circumstances for a new gene therapy, Upstaza* (eladocagene exuparvovec). It is the first medicine intended to treat adult and paediatric patients with aromatic L‑amino acid decarboxylase (AADC) deficiency, an ultra-rare genetic disorder affecting the nervous system. See more information in the news announcement in the grid below.

Xenpozyme* (olipudase alfa) received a positive opinion for the treatment of two types of Niemann-Pick disease, a rare metabolic disorder caused by acid sphingomyelinase deficiency (ASMD). Xenpoxyme is the first ASMD-specific treatment and was supported through EMA's PRIority MEdicines (PRIME) scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. See more information in the news announcement in the grid below.

A positive opinion under exceptional circumstances was adopted for Zokinvy* (ionafarnib), the first treatment for children with progeroid syndromes, an ultra-rare genetic disease which causes premature aging and death. See more information in the news announcement in the grid below.

Kinpeygo* (budesonide), a hybrid medicine indicated for the treatment of primary immunoglobulin A nephropathy in adults, received a positive opinion from the CHMP. Hybrid medicines 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.

Four generic medicines received a positive opinion from the Committee: Ertapenem SUN (ertapenem), intended for the treatment of ertapenem-susceptible bacterial infection; Ganirelix Gedeon Richter (ganirelix), for the prevention of premature ovulation in women receiving fertility treatment and who are having ovarian stimulation; Sitagliptin / Metformin hydrochloride Accord (sitagliptin / metformin hydrochloride), a treatment for type 2 diabetes mellitus; and Sugammadex Fresenius Kabi (sugammadex), a medicine intended for reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Negative opinions for two new biosimilar medicines

The CHMP recommended the refusal of marketing authorisations for Tuznue (trastuzumab), a biosimilar medicine intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer and for its duplicate Hervelous (trastuzumab). For more information on these negative opinions, see the question-and-answer documents in the grid below.

Recommendations on extensions of therapeutic indication for six medicines

The Committee recommended six extensions of indication for medicines that are already authorised in the European Union: CosentyxKeytrudaNexpovioOlumiantRinvoq and Xeljanz.

Review of impact of flawed bioequivalence data concluded

The CHMP recommended the suspension of marketing authorisations for some 100 medicines which obtained approval on the basis of flawed bioequivalence studies conducted by the contract research organisation Synchron Research Services, located in Ahmedabad, India. For around 20 medicines included in this review, bioequivalence data from other sources are available and therefore they are allowed to remain on the EU market. For more information about this review, see the public health communication in the grid below.

Conclusion of arbitration referral

The CHMP completed a review of Daruph/Anafezyn under Article 29(4) following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Daruph/Anafezyn outweigh its risks, and the marketing authorisation should be granted in the Member States of the EU where the company applied for a marketing authorisation (France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania, Sweden and Slovakia). Daruph/Anafezyn is a cancer medicine to be used in adults and children to treat chronic myeloid leukaemia and acute lymphoblastic leukaemia. For more information about this referral, see the public health communication in the grid below.

Withdrawals of applications

The applications for a marketing authorisation for HemAryo (eptacog alfa (activated)) and Sitoiganap (allogeneic and autologous haptenised and irradiated cells and cell lysates derived from glioma) were withdrawn by the respective applicants. HemAryo was intended for the treatment of bleeding episodes and for the prevention of bleeding after surgical procedures in patients with clotting disorders. Sitoiganap was meant to treat adults with malignant glioma, a type of brain cancer that is progressive or recurrent after treatment. Question-and-answer documents on the withdrawals are available in the grid below.

COVID-19 update

The CHMP recommended authorising a booster dose (third dose) of Vaxzevria for adults who completed the primary vaccination course with this vaccine or an approved mRNA COVID-19 vaccine.

Agenda and minutes

The agenda of the May 2022 CHMP meeting is published on EMA's website. Minutes of the April 2022 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the May 2022 CHMP meeting are represented in the graphic below.

CHMP statistics: May 2022


*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 medicineCevenfacta
International non-proprietary name (INN)eptacog beta (activated)
Marketing-authorisation applicantLaboratoire Francais du Fractionnement et des Biotechnologies
Therapeutic indicationTreatment of bleeding episodes in patients with congenital haemophilia
More informationCevenfacta: Pending EC decision

 

Name of medicineUpstaza
INNeladocagene exuparvovec
Marketing-authorisation applicantPTC Therapeutics International Limited
Therapeutic indicationTreatment of aromatic L‑amino acid decarboxylase (AADC) deficiency
More information

Upstaza: Pending EC decision

News announcement: First therapy to treat rare genetic nervous system disorder AADC deficiency 

 

Name of medicineXenpozyme
INNolipudase alfa
Marketing-authorisation applicantGenzyme Europe BV
Therapeutic indicationTreatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) type A/B or type B
More information

Xenpozyme: Pending EC decision

News announcement: First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder

 

Name of medicineZokinvy
INNlonafarnib
Marketing-authorisation applicantEigerBio Europe Limited
Therapeutic indicationTreatment of progeroid syndromes
More information

Zokinvy: Pending EC decision

News announcement: First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)

 

Positive recommendations on new generic medicines

Name of medicineErtapenem SUN
INNertapenem
Marketing-authorisation applicantSUN Pharmaceutical Industries (Europe) B.V.
Therapeutic indicationTreatment of ertapenem-susceptible bacterial infection and prevention of surgical site infection following elective colorectal surgery
More informationErtapenem SUN: Pending EC decision

 

Name of medicineGanirelix Gedeon Richter
INNganirelix
Marketing-authorisation applicantChemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Therapeutic indicationPrevention of premature ovulation in women receiving fertility treatment and who are having ovarian stimulation
More informationGanirelix Gedeon Richter: Pending EC decision

 

Name of medicineSitagliptin / Metformin hydrochloride Accord
INNsitagliptin / metformin hydrochloride
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSitagliptin / Metformin hydrochloride Accord: Pending EC decision

 

Name of medicineSugammadex Fresenius Kabi
INNsugammadex
Marketing-authorisation applicantFresenius Kabi Deutschland GmbH
Therapeutic indicationReversal of neuromuscular blockade induced by rocuronium or vecuronium
More informationSugammadex Fresenius Kabi: Pending EC decision

 

Positive recommendation on new hybrid medicine

Name of medicineKinpeygo
INNbudesonide
Marketing-authorisation applicantCalliditas Therapeutics AB
Therapeutic indicationTreatment of primary immunoglobulin A nephropathy
More informationKinpeygo: Pending EC decision

 

Withdrawal of initial marketing authorisation applications

Name of medicineHemAryo
INNeptacog alfa (activated)
Marketing-authorisation applicantUGA Biopharma
Therapeutic indicationTreatment and prevention of bleeding episodes
More informationHemAryo: Withdrawn application

 

Name of medicineSitoiganap
Common nameautologous glioma tumour cells, inactivated / autologous glioma tumour cell lysates, inactivated / allogeneic glioma tumour cells, inactivated / allogeneic glioma tumour cell lysates, inactivated
Marketing-authorisation applicantEpitopoietic Research Corporation-Belgium (E.R.C.)
Therapeutic indicationTreatment of glioma
More informationSitoiganap: Withdrawn application

 

Positive recommendations on extensions of indications

Name of medicineCosentyx
INNsecukinumab
Marketing-authorisation holderNovartis Europharm Limited
More information

 

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More information 

 

Name of medicineNexpovio
INNselinexor
Marketing-authorisation holderKaryopharm Europe GmbH
More informationNexpovio: Pending EC decision

 

Name of medicineOlumiant
INNbaricitinib
Marketing-authorisation holderEli Lilly Nederland B.V.
More information

 

Name of medicineRinvoq
INNupadacitinib
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More informationRinvoq: Pending EC decision

 

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation holderPfizer Europe MA EEIG
More informationXeljanz: Pending EC decision

 

Negative recommendations on new biosimilar medicines

Name of medicineHervelous
INNtrastuzumab
Marketing-authorisation applicantPrestige Biopharma Belgium
Therapeutic indicationTreatment of certain forms of breast cancer and gastric (stomach) cancer
More informationHervelous: Pending EC decision

 

Name of medicineTuznue
INNtrastuzumab
Marketing-authorisation applicantPrestige Biopharma Belgium
Therapeutic indicationTreatment of certain forms of breast cancer and gastric (stomach) cancer
More informationTuznue: Pending EC decision

 

Conclusion of referral under Article 29(4)

Name of medicineDaruph and Anafezyn
INNdasatinib (anhydrous)
More informationDaruph and Anafezyn

 

Conclusion of referral under Article 31

Name of referralSynchron
INNvarious
More informationSynchron

 

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