Highlights from the CHMP September Meeting

September 26, 2014
Pharmaceutical Technology Editors

CHMP has recommended 15 new medicines for approval and three extensions of indication.

In the September meeting of the Committee for Medicinal Products for Human Use (CHMP), the following 15 medicines were recommended for approval.

  • Harvoni (sofosbuvir/ledipasvir) for the treatment of chronic hepatitis C in adults.

  • Ketoconazole HRA (ketoconazole), an orphan drug, for the treatment for patients with Cushing’s syndrome.

  • Vargatef (nintedanib) for the treatment of non-small cell lung cancer.  

  • Cyramza (ramucirumab), an orphan drug, for the treatment of gastric cancer.

  • Diagnostic agent Lymphoseek (tilmanocept) for the delineation and localization of sentinel lymph nodes.

  • Egranli (balugrastim) for the treatment of chemotherapy-induced neutropenia.

  • Rezolsta (darunavir/cobicistat) for the treatment of human immunodeficiency virus (HIV).

  • Trulicity (dulaglutide) for the treatment of type 2 diabetes.

  • Moventig (naloxegol) for the treatment of opioid-induced constipation.

  • Generic drug Tadalafil Mylan for the treatment of erectile dysfunction in adult males.

  • Brimica Genuair and Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD).

  • Budesonide/Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD.

  • Budesonide/Formoterol Teva Pharma B.V. for the treatment of asthma.


The Committee also recommended three extensions of therapeutic indications—Signifor and two extensions of indication for Prezista.

Re-examination procedure
After a re-examination of Avastin, the CHMP adopted a final negative opinion on the request for an extension of indication in the treatment of adult patients with newly diagnosed glioblastoma.

Review on GVK Bio Research Centre, India
EMA has started a review concerning the findings of non-compliance with good clinical practice (GCP) at GVK Biosciences site in Hyderabad, India, following an inspection by the French medicines agency (ANSM). This issue raised concerns about study data used to support the marketing authorization applications of generic medicines.

Benefit-risk review
Following the completion of a routine benefit-risk review of the antidepressant medicine Valdoxan/Thymanax, the Committee has concluded that its benefits outweigh the risks. However, the agency has recommended that further measures should be put in place to improve monitoring of liver function during treatment.

Closure of EU manufacturing site for Maci
The EU manufacturing site for the advanced therapy medicine Maci (matrix-applied characterized autologous cultured chondrocytes) has been closed for commercial reasons. Arrangements are in place for existing patients to complete their treatment.

Ebola crisis prompts EMA to review experimental medicines to support treatment decisions
EMA is reviewing all Ebola treatments currently under development in a move to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities.

Patients discuss benefit-risk evaluation of medicines with the CHMP
EMA has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in CHMP meetings.

Agenda and minutes
The agenda is available on EMA’s website and the minutes of the meeting will be published during the week following the October CHMP meeting.

Source: EMA