Three new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended three medicines for approval at its June 2019 meeting.

The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock.

Two informed consent applications received a positive opinion from the CHMP: Azacitidine Celgene (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia; and Lacosamide UCB (lacosamide), for the treatment of partial-onset seizures with or without secondary generalisation. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Negative opinion on a new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Evenity (romosozumab). Evenity was expected to be used to treat osteoporosis. For more information, please see the question-and-answer document in the grid below.

Start of re-examination of recommendation for new medicine

The applicant for Xyndari (glutamine) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the May 2019 meeting. The CHMP will now re-examine the opinion and issue a final recommendation. For more information on this negative opinion, please see the question-and-answer document in the grid below.

New paediatric indication for type 2 diabetes medicine

The CHMP recommended an extension of indication for Victoza (liraglutide) to include the treatment of children and adolescents aged ten years or older with type 2 diabetes. For more information, please see the press release in the grid below.

Other extensions of indication recommended by the Committee were for Cyramza, Dupixent, Ebymect, Edistride, Fiasp, Flebogamma DIF, Forxiga, Imbruvica, Tecentriq, Xigduo and Zinforo

Negative opinions on extension of therapeutic indication

The CHMP adopted a negative opinion for an extension of therapeutic indication for Revolade (eltrombopag) to add the treatment of previously untreated patients with severe aplastic anaemia from two years of age.

The Committee also adopted a negative opinion for an extension of the therapeutic indication of Translarna (ataluren) to add the treatment of patients with Duchenne muscular dystrophy who are no longer able to walk.

For more information on these negative opinions, please see the question-and-answer documents in the grid below.

Outcome of review on bacterial lysate medicines for respiratory conditions

The CHMP recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes. For more information, please see the public health recommendation in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for ABP 710 (infliximab) was withdrawn. This medicine was intended for treatment of some inflammatory diseases. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the June 2019 meeting is published on EMA's website. Minutes of the May 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the June 2019 CHMP meeting are represented in the graphic below.

CHMP statistics: June 2019

Positive recommendation on new medicine

Name of medicineGiapreza
International non-proprietary name (INN)angiotensin II
Marketing-authorisation applicantLa Jolla Pharmaceutical II B.V.
Therapeutic indicationTreatment of refractory hypotension in adults with septic or other distributive shock
More information Giapreza: Pending EC decision

 

Positive recommendations on new informed consent medicines

Name of medicineAzacitidine Celgene
INNazacitidine
Marketing-authorisation applicantCelgene Europe BV
Therapeutic indicationTreatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia
More information Azacitidine Celgene: Pending EC decision

 

Name of medicineLacosamide UCB 
INNlacosamide
Marketing-authorisation applicantUCB Pharma S.A.
Therapeutic indicationTreatment of partial-onset seizures with or without secondary generalisation
More informationLacosamide UCB: Pending EC decision

 

Negative recommendation on new medicine

Name of medicineEvenity
INNromosozumab
Marketing-authorisation applicantUCB Pharma S.A.
Therapeutic indicationTreatment of osteoporosis
More informationEvenity: Pending EC decision

 

Start of re-examination of recommendation for new medicine

Name of medicineXyndari
INNglutamine
Marketing-authorisation applicantEmmaus Medical Europe Ltd
Therapeutic indicationTreatment of sickle cell disease
More informationXyndari: Pending EC decision

Positive recommendations on extensions of indications

Name of medicineCyramza
INNramucirumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationCyramza: Pending EC decision

 

Name of medicineDupixent
INNdupilumab
Marketing-authorisation holdersanofi-aventis groupe
More informationDupixent: Pending EC decision

 

Name of medicineEbymect
INNdapagliflozin / metformin
Marketing-authorisation holderAstraZeneca AB
More informationEbymect: Pending EC decision

 

Name of medicineEdistride
INNdapagliflozin
Marketing-authorisation holderAstraZeneca AB
More informationEdistride: Pending EC decision

 

Name of medicineFiasp
INNinsulin aspart
Marketing-authorisation holderNovo Nordisk A/S
More informationFiasp: Pending EC decision

 

Name of medicineFlebogamma DIF
INNhuman normal immunoglobulin
Marketing-authorisation holderInstituto Grifols, S.A.
More informationFlebogamma DIF (previously Flebogammadif): Pending EC decision

 

Name of medicineForxiga
INNdapagliflozin
Marketing-authorisation holderAstraZeneca AB
More informationForxiga: Pending EC decision

 

Name of medicineImbruvica
INNibrutinib
Marketing-authorisation holderJanssen-Cilag International NV
More informationImbruvica: Pending EC decision
Name of medicineTecentriq
INNatezolizumab
Marketing-authorisation holderRoche Registration GmbH
More informationTecentriq: Pending EC decision

 

Name of medicineVictoza
INNliraglutide
Marketing-authorisation holderNovo Nordisk A/S
More information

Victoza: Pending EC decision

Press release:New treatment for children with type 2 diabetes

 

Name of medicineXigduo
INNdapagliflozin / metformin
Marketing-authorisation holderAstraZeneca AB
More informationXigduo: Pending EC decision

 

Name of medicineZinforo
INNceftaroline fosamil
Marketing-authorisation holderPfizer Ireland Pharmaceuticals
More informationZinforo: Pending EC decision

 

Negative recommendations on extension of indications

Name of medicineRevolade
INNeltrombopag
Marketing-authorisation holderNovartis Europharm Limited
More informationRevolade: Pending EC decision

 

Name of medicineTranslarna
INNataluren
Marketing-authorisation holderPTC Therapeutics International Limited
More informationTranslarna: Pending EC decision

 

Public-health recommendation

Name of medicineBacterial lysates-containing medicinal products indicated for respiratory conditions
INNHaemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis
More informationBacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

Withdrawal of initial marketing authorisation application

Name of medicineABP 710
INNinfliximab
Marketing-authorisation applicantAmgen Europe B.V.
More informationABP 710: Withdrawn application

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 June 2019

Overview of (invented) names reviewed in May 2019 by the Name Review Group (NRG) adopted at the CHMP meeting of 24-27 June 2019

Start of Union reviews adopted during the CHMP meeting of 24 - 27 June 2019

Scientific advice and protocol assistance adopted during the CHMP meeting 24 – 27 June 2019

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