Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019

News 01/02/2019

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

The CHMP adopted a positive opinion for Ajovy (fremanezumab), for the prophylaxis of migraine.

Vizimpro (dacomitinib) received a positive opinion for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor activating mutations.

Two biosimilar medicines for the treatment of certain inflammatory and autoimmune disorders received a positive opinion from the Committee: Idacio (adalimumab) and Kromeya (adalimumab).

The CHMP recommended granting marketing authorisations for two generic medicines: Atazanavir Krka (atazanavir), for the treatment of HIV-1 infection in adults and children 6 years of age and older, and Febuxostat Krka (febuxostat), for the prevention and treatment of hyperuricaemia.

Negative opinion on a new medicine

The CHMP adopted a negative opinion refusing a marketing authorisation for Doxolipad (doxorubicin). Developed as a hybrid medicine, Doxolipad was expected to be used to treat breast and ovarian cancer. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data. For more information please see the question-and-answer document in the grid below.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Edistride, Forxiga, Hemlibra, Keytruda, Mabthera, Maviret, Orencia, Praluent and Tecentriq.

The CHMP recommended an extension of indication of Forxiga and its duplicate Edistride to include for the first time adjunct treatment with insulin for certain patients with type 1 diabetes. For more information about these extensions, please see the press release in the grid below.

Outcome of review of impurities in sartan medicines

Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities. This recommendation follows the CHMP’s review of N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA), which are classified as probable human carcinogens (substances that could cause cancer) and have been detected in some sartan medicines.

For more information, please see the public health recommendation in the grid below.

Start of referrals

The CHMP started a review of a study of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban). This observational study assessed the risk of major bleedings with these medicines when used to prevent blood clotting in patients with non-valvular atrial fibrillation (irregular rapid contractions of the heart), in comparison with other oral anticoagulants. The review will assess whether the results of the study have implications on the use of the medicines.

The Committee also started a review of the cancer medicine Lartruvo (olaratumab) after preliminary results from the ANNOUNCE study became available which showed that adding Lartruvo to doxorubicin does not prolong the lives of patients with soft tissue sarcoma more than doxorubicin alone.

For more information, please see the start-of-referral documents in the grid below.

Start of re-examination of recommendation on omega-3 fatty acid medicines

Following the CHMP’s recommendation of 13 December 2018 on omega-3 fatty acid medicines, some of the marketing authorisation holders involved with this review have requested a re-examination. Upon receipt of the grounds for their requests, the CHMP will start a re-examination and issue its final recommendation.

For more information on this review, please see the public health recommendation in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Cavoley (pegfilgrastim), Efgratin (pegfilgrastim) and Vynpenta (avacopan) have been withdrawn. Cavoley and Efgratin were intended to be used to reduce neutropenia.

Vynpenta (previously known as AvacopanChemocentryx) was intended to be used to treat the blood vessel disorders granulomatosis with polyangiitis and microscopic polyangiitis. It was accepted in EMA’s PRIority Medicines (PRIME) scheme in May 2016.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the January 2019 meeting is published on EMA's website. Minutes of the December 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

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

CHMP statistics: January 2019

Positive recommendations on new medicines

Name of medicineAjovy
International non-proprietary name (INN)fremanezumab
Marketing-authorisation applicantTEVA GmbH
Therapeutic indication

Prophylaxis of migraine.

Name of medicineVizimpro
INNdacomitinib
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indication

Treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) activating mutations.

Positive recommendations on new generic medicines

Name of medicineAtazanavir Krka
INNatazanavir
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indication

Treatment of HIV-1 infection in adults and children 6 years of age and older.

Name of medicineFebuxostat Krka 
INNfebuxostat
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indication

Prevention and treatment of hyperuricaemia.

Positive recommendations on new biosimilar medicines

Name of medicineIdacio
INNadalimumab
Marketing-authorisation applicantFresenius Kabi Deutschland GmbH
Therapeutic indication

Treatment of certain inflammatory and autoimmune disorders.

Name of medicineKromeya
INNadalimumab
Marketing-authorisation applicantFresenius Kabi Deutschland GmbH
Therapeutic indication

Treatment of certain inflammatory and autoimmune disorders.

Negative recommendation on a new medicine

Name of medicineDoxolipad
INNdoxorubicin hydrochloride
Marketing-authorisation applicantTLC Biopharmaceuticals B.V.
Therapeutic indication

Treatment of breast and ovarian cancer.

Positive recommendations on extensions of indications

Name of medicineEdistride
INNdapagliflozin
Marketing-authorisation holder

AstraZeneca AB

More informationFirst oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
Name of medicineForxiga
INNdapagliflozin
Marketing-authorisation holder

AstraZeneca AB

More informationFirst oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
Name of medicineHemlibra
INNemicizumab
Marketing-authorisation holder

Roche Registration GmbH

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holder

Merck Sharp & Dohme B.V.

Name of medicineMabthera
INNrituximab
Marketing-authorisation holder

Roche Registration GmbH

Name of medicineMaviret
INNglecaprevir / pibrentasvir
Marketing-authorisation holder

AbbVie Deutschland GmbH & Co. KG

Name of medicineOrencia
INNabatacept
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Name of medicinePraluent
INNalirocumab
Marketing-authorisation holder

sanofi-aventis groupe

Name of medicineTecentriq
INNatezolizumab
Marketing-authorisation holder

Roche Registration GmbH

Public-health recommendation

Name of medicineAngiotensin-II-receptor antagonists (sartans) containing a tetrazole group
More information

Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Start of referrals

Name of medicineDirect oral anticoagulants
More information 
Name of medicineLartruvo
INNolaratumab
More informationReview of cancer medicine Lartruvo started

Start of re-examination of public-health recommendation

Name of medicineOmega-3 fatty acid medicines
More information

Omega-3 fatty acid medicines: Article 31 referrals

Withdrawal of initial marketing authorisation applications

Name of medicineCavoley
INNpegfilgrastim
Marketing-authorisation applicant

STADA Arzneimittel AG

More information 

 

Name of medicineEfgratin
INNpegfilgrastim
Marketing-authorisation applicant

Gedeon Richter Plc.

More information 
Name of medicineVynpenta (previously AvacopanChemocentryx)
INNavacopan
Marketing-authorisation applicant

ChemoCentryx Ltd.

More information 

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