Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019
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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.
Positive recommendations on new medicines
| Name of medicine | Ajovy |
|---|---|
| International non-proprietary name (INN) | fremanezumab |
| Marketing-authorisation applicant | TEVA GmbH |
| Therapeutic indication | Prophylaxis of migraine. |
| Name of medicine | Vizimpro |
|---|---|
| INN | dacomitinib |
| Marketing-authorisation applicant | Pfizer 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 medicine | Atazanavir Krka |
|---|---|
| INN | atazanavir |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Treatment of HIV-1 infection in adults and children 6 years of age and older. |
| Name of medicine | Febuxostat Krka |
|---|---|
| INN | febuxostat |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Prevention and treatment of hyperuricaemia. |
Positive recommendations on new biosimilar medicines
| Name of medicine | Idacio |
|---|---|
| INN | adalimumab |
| Marketing-authorisation applicant | Fresenius Kabi Deutschland GmbH |
| Therapeutic indication | Treatment of certain inflammatory and autoimmune disorders. |
| Name of medicine | Kromeya |
|---|---|
| INN | adalimumab |
| Marketing-authorisation applicant | Fresenius Kabi Deutschland GmbH |
| Therapeutic indication | Treatment of certain inflammatory and autoimmune disorders. |
Negative recommendation on a new medicine
| Name of medicine | Doxolipad |
|---|---|
| INN | doxorubicin hydrochloride |
| Marketing-authorisation applicant | TLC Biopharmaceuticals B.V. |
| Therapeutic indication | Treatment of breast and ovarian cancer. |
Positive recommendations on extensions of indications
| Name of medicine | Edistride |
|---|---|
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes |
| Name of medicine | Forxiga |
|---|---|
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes |
| Name of medicine | Hemlibra |
|---|---|
| INN | emicizumab |
| Marketing-authorisation holder | Roche Registration GmbH |
| Name of medicine | Keytruda |
|---|---|
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| Name of medicine | Mabthera |
|---|---|
| INN | rituximab |
| Marketing-authorisation holder | Roche Registration GmbH |
| Name of medicine | Maviret |
|---|---|
| INN | glecaprevir / pibrentasvir |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| Name of medicine | Orencia |
|---|---|
| INN | abatacept |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| Name of medicine | Praluent |
|---|---|
| INN | alirocumab |
| Marketing-authorisation holder | sanofi-aventis groupe |
| Name of medicine | Tecentriq |
|---|---|
| INN | atezolizumab |
| Marketing-authorisation holder | Roche Registration GmbH |
Public-health recommendation
| Name of medicine | Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group |
|---|---|
| More information |
| Name of medicine | Direct oral anticoagulants |
|---|---|
| More information |
| Name of medicine | Lartruvo |
|---|---|
| INN | olaratumab |
| More information | Review of cancer medicine Lartruvo started |
Start of re-examination of public-health recommendation
| Name of medicine | Omega-3 fatty acid medicines |
|---|---|
| More information |
| Name of medicine | Cavoley |
|---|---|
| INN | pegfilgrastim |
| Marketing-authorisation applicant | STADA Arzneimittel AG |
| More information |
| Name of medicine | Efgratin |
|---|---|
| INN | pegfilgrastim |
| Marketing-authorisation applicant | Gedeon Richter Plc. |
| More information |
| Name of medicine | Vynpenta (previously AvacopanChemocentryx) |
|---|---|
| INN | avacopan |
| Marketing-authorisation applicant | ChemoCentryx Ltd. |
| More information |