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 medicine Cevenfacta
International non-proprietary name (INN) eptacog beta (activated)
Marketing-authorisation applicant Laboratoire Francais du Fractionnement et des Biotechnologies
Therapeutic indication Treatment of bleeding episodes in patients with congenital haemophilia
More information Cevenfacta: Pending EC decision

Name of medicine Upstaza
INN eladocagene exuparvovec
Marketing-authorisation applicant PTC Therapeutics International Limited
Therapeutic indication Treatment of aromatic L‑amino acid decarboxylase (AADC) deficiency
More information

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

Name of medicine Xenpozyme
INN olipudase alfa
Marketing-authorisation applicant Genzyme Europe BV
Therapeutic indication Treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) type A/B or type B
More information

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

Name of medicine Zokinvy
INN lonafarnib
Marketing-authorisation applicant EigerBio Europe Limited
Therapeutic indication Treatment of progeroid syndromes
More information

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

Positive recommendations on new generic medicines

Name of medicine Ertapenem SUN
INN ertapenem
Marketing-authorisation applicant SUN Pharmaceutical Industries (Europe) B.V.
Therapeutic indication Treatment of ertapenem-susceptible bacterial infection and prevention of surgical site infection following elective colorectal surgery
More information Ertapenem SUN: Pending EC decision

Name of medicine Ganirelix Gedeon Richter
INN ganirelix
Marketing-authorisation applicant Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Therapeutic indication Prevention of premature ovulation in women receiving fertility treatment and who are having ovarian stimulation
More information

Name of medicine Sitagliptin / Metformin hydrochloride Accord
INN sitagliptin / metformin hydrochloride
Marketing-authorisation applicant Accord Healthcare S.L.U.
Therapeutic indication Treatment of type 2 diabetes mellitus
More information

Name of medicine Sugammadex Fresenius Kabi
INN sugammadex
Marketing-authorisation applicant Fresenius Kabi Deutschland GmbH
Therapeutic indication Reversal of neuromuscular blockade induced by rocuronium or vecuronium
More information

Positive recommendation on new hybrid medicine

Name of medicine Kinpeygo
INN budesonide
Marketing-authorisation applicant Calliditas Therapeutics AB
Therapeutic indication Treatment of primary immunoglobulin A nephropathy
More information

Withdrawal of initial marketing authorisation applications

Name of medicine HemAryo
INN eptacog alfa (activated)
Marketing-authorisation applicant UGA Biopharma
Therapeutic indication Treatment and prevention of bleeding episodes
More information HemAryo: Withdrawn application

Name of medicine Sitoiganap
Common name autologous glioma tumour cells, inactivated / autologous glioma tumour cell lysates, inactivated / allogeneic glioma tumour cells, inactivated / allogeneic glioma tumour cell lysates, inactivated
Marketing-authorisation applicant Epitopoietic Research Corporation-Belgium (E.R.C.)
Therapeutic indication Treatment of glioma
More information Sitoiganap: Withdrawn application

Positive recommendations on extensions of indications

Name of medicine Cosentyx
INN secukinumab
Marketing-authorisation holder Novartis Europharm Limited
More information Cosentyx: Pending EC decision

Name of medicine Keytruda
INN pembrolizumab
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Keytruda: Pending EC decision

Name of medicine Nexpovio
INN selinexor
Marketing-authorisation holder Karyopharm Europe GmbH
More information

Name of medicine Olumiant
INN baricitinib
Marketing-authorisation holder Eli Lilly Nederland B.V.
More information Olumiant: Pending EC decision

Name of medicine Rinvoq
INN upadacitinib
Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG
More information

Name of medicine Xeljanz
INN tofacitinib
Marketing-authorisation holder Pfizer Europe MA EEIG
More information Xeljanz: Pending EC decision

Negative recommendations on new biosimilar medicines

Name of medicine Hervelous
INN trastuzumab
Marketing-authorisation applicant Prestige Biopharma Belgium
Therapeutic indication Treatment of certain forms of breast cancer and gastric (stomach) cancer
More information Hervelous: Pending EC decision

Name of medicine Tuznue
INN trastuzumab
Marketing-authorisation applicant Prestige Biopharma Belgium
Therapeutic indication Treatment of certain forms of breast cancer and gastric (stomach) cancer
More information Tuznue: Pending EC decision

Conclusion of referral under Article 29(4)

Name of medicine Daruph and Anafezyn
INN dasatinib (anhydrous)
More information Daruph and Anafezyn

Conclusion of referral under Article 31

Name of referral Synchron
INN various
More information Synchron

Related content

How useful was this page?

Add your rating
Average
1 rating