Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019

News 26/04/2019

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

The Committee recommended granting a marketing authorisation for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. For more information, please see the press release in the grid below.

Two orphan medicines1 received a positive opinion from the CHMP: Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency), and Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

Doptelet (avatrombopag) received a positive opinion for the treatment of severe thrombocytopenia.

The Committee adopted a positive opinion for Dovato (dolutegravir / lamivudine), for the treatment of HIV infection.

The CHMP recommended the granting of a conditional marketing authorisation for Libtayo (cemiplimab), for the treatment of advanced cutaneous squamous cell carcinoma.

The Committee adopted a positive opinion for Nuceiva (botulinum toxin type a), intended for temporary improvement of vertical lines between the eyebrows, when the severity of the facial lines has an important psychological impact in adults below 65 years of age.

Talzenna (talazoparib) received a positive opinion for the treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer.

The biosimilar medicine Grasustek (pegfilgrastim) received a positive opinion for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.

The CHMP recommended granting marketing authorisations for two generic medicines: Ambrisentan Mylan (ambrisentan), for the treatment of pulmonary arterial hypertension, and Striascan (ioflupane (123I)), a radiopharmaceutical intended for the diagnosis of Parkinson’s disease and other related diseases and dementia.

The Committee granted a positive opinion for Xromi (hydroxycarbamide), a hybrid medicine for the prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age. Hybrid applications 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.

Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol), an informed consent application for the maintenance treatment of adults patients with moderate to severe chronic obstructive pulmonary disease, received a positive opinion from the CHMP. 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 refusing a marketing authorisation for Cabazitaxel Teva (cabazitaxel). Developed as a hybrid medicine, Cabazitaxel Teva was expected to be used to treat prostate cancer. For more information please see the question-and-answer document in the grid below.

One recommendation on extension of therapeutic indication

The Committee recommended an extension of indication for Lynparza.

Revocation of marketing authorisation for Lartruvo

The CHMP completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. Therefore, the Committee recommended that the conditional marketing authorisation of the medicine be revoked.

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

Update on nitrosamine impurities

Following an EU safety review, which concluded on strict legally binding limits for nitrosamine impurities in sartan blood pressure medicines, EMA continues to work closely with national authorities and international partners to ensure manufacturers are taking appropriate measures to avoid or keep presence of nitrosamine below the acceptable limits. Based on experience from the review of sartans, EMA is launching an exercise with experts from across the EU regulatory network to consider how to prevent such incidents in future and to see if their management can be improved, should they occur. EMA will publish the outcome of the exercise in due course.

As part of strengthened monitoring of manufacturing, EMA and national authorities are also requesting as precaution that companies using certain reagents to manufacture the diabetes medicine pioglitazone test their products and check their processes to rule out the presence of nitrosamine impurities, in particular nitrosodimethylamine (NDMA). The request follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India.

For more information, please see the ‘Update on nitrosamine impurities’ document in the grid below.

Update on prescribing information for Tyverb

EMA is updating the prescribing information for Tyverb (lapatinib) following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab. The results had indicated a benefit of Tyverb over trastuzumab when each medicine was used together with an aromatase inhibitor. 

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

Agenda and minutes

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

CHMP statistics

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

 

Due to the late start and finishing of the meeting, further updates may be made on Monday, 29 April 2019. Please check the CHMP highlights again.


1 As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.

CHMP statistics: April 2019

Positive recommendations on new medicines

Name of medicineDoptelet
International non-proprietary name (INN)avatrombopag
Marketing-authorisation applicantDova Pharmaceuticals Ireland Limited
Therapeutic indication

Treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure

 

Name of medicineDovato
INNdolutegravir / lamivudine
Marketing-authorisation applicantViiV Healthcare B.V.
Therapeutic indication

Treatment of human immunodeficiency virus type 1 (HIV-1)

 

Name of medicineEsperoct
INNturoctocog alfa pegol
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indication

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency)

 

Name of medicineLibtayo
INNcemiplimab
Marketing-authorisation applicantRegeneron Ireland U.C.
Therapeutic indication

Treatment of advanced cutaneous squamous cell carcinoma

 

Name of medicineNuceiva
INNbotulinum toxin type A
Marketing-authorisation applicantEvolus Pharma Limited
Therapeutic indication

Temporary improvement of vertical lines between the eyebrows, when the severity of the above facial lines has an important psychological impact in adults below 65 years of age

 

Name of medicineSixmo
INNbuprenorphine
Marketing-authorisation applicantL. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
Therapeutic indication

Substitution treatment for opioid drug dependence

More informationNew long-lasting implant to treat opioid dependence

 

Name of medicineTalzenna
INNtalazoparib
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indication

Treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer

 

Name of medicineUltomiris 
INNravulizumab 
Marketing-authorisation applicantAlexion Europe SAS
Therapeutic indication

Treatment of adult patients with paroxysmal nocturnal hemoglobinuria

Positive recommendation on new biosimilar medicine

Name of medicineGrasustek
INNpegfilgrastim
Marketing-authorisation applicantJuta Pharma GmbH
Therapeutic indication

Prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy

Positive recommendations on new generic medicines

Name of medicineAmbrisentan Mylan 
INNambrisentan
Marketing-authorisation applicantMYLAN S.A.S.
Therapeutic indication

Treatment of pulmonary arterial hypertension

 

Name of medicineStriascan
INNioflupane (123I)
Marketing-authorisation applicantCIS BIO International
Therapeutic indication

Diagnosis of Parkinson’s disease and other related diseases and dementia

Positive recommendations on new informed consent medicines

Name of medicineTemybric Ellipta
INNfluticasone furoate / umeclidinium / vilanterol 
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indication

Maintenance treatment of adults patients with moderate to severe chronic obstructive pulmonary disease

Positive recommendations on new hybrid medicines

Name of medicineXromi
INNhydroxycarbamide
Marketing-authorisation applicantNova Laboratories Ireland Limited
Therapeutic indication

Prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age

Negative recommendation for new medicine

Name of medicineCabazitaxel Teva 
INNcabazitaxel
Marketing-authorisation applicantTeva B.V.
Therapeutic indication

Treatment of prostate cancer

Positive recommendations on extensions of indications

Name of medicine
Lynparza
INNolaparib
Marketing-authorisation holder

AstraZeneca AB

Public-health recommendation

Name of medicineLartruvo
INNolaratumab
More information

EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo (updated on 30/04/2019)

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