CHMP News – September 2014
01.10.2014
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) adopted the following recommendations with regard to human medicinal products.
CHMP recommended approval of fifteen new medicines
The CHMP recommended approval of fifteen new medicines by adopting the following recommendations:
- for Harvoni (sofosbuvir/ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antivirus medicines for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease;
- for Ketoconazole HRA (ketoconazole) for the treatment of Cushing’s syndrome. Pharmacological options for this syndrome remain very limited and there is an unmet medical need for additional medicines. Ketoconazole has an orphan designation;
- for Vargatef (nintedanib) for the treatment of non-small cell lung cancer;
- for Cyramza (ramucirumab) for the treatment of gastric cancer;
- for the diagnostic agent Lymphoseek (tilmanocept) for the delineation and localisation of sentinel lymph nodes;
- for Egranli (balugrastim) for the treatment of chemotherapy-induced neutropenia;
- for Rezolsta (darunavir/cobicistat) for the treatment of HIV infection;
- for Trulicity (dulaglutid) for the treatment of type 2 diabetes;
- for Moventig (naloxegol) for the treatment of opioid-induced constipation;
- for the generic medicine Tadalafil Mylan for the treatment of erectile dysfunction in adult males;
- for the medicines Brimica Genuair and Duaklir Genuair (aclidinium/formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD);
- for the hybrid applications Budesonide/Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD and Budesonide/Formoterol Teva Pharma B.V. for the treatment of asthma.
Three recommendations on extensions of therapeutic indications
The CHMP recommended an extension of indications for Signifor and two extensions of indication for Prezista.
Outcome of re-examination procedure
The CHMP concluded a re-examination procedure for Avastin, adopting a final negative opinion on a request for an extension of indication in the treatment of adult patients with newly diagnosed glioblastoma.
Review underway concerning conduct of studies at GVK Bio Research Centre, India
The EMA has started a review in relation to findings of non-compliance with good clinical practice (GCP) at GVK Biosciences site in Hyderabad, India. This follows and inspection by the French Medicines Agency (ANSM) which raised concerns about study data used to support the marketing authorisation application of generic medicines.
Outcome of benefit-risk review
The CHMP has completed a routine benefit-risk review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to 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 characterised autologous cultured chondrocytes) has been closed for commercial reasons. Arrangements are in place for existing patients to complete their treatment.
Ebola outbreak: EMA to review experimental medicines to support treatment decisions
The EMA has started to review available information on Ebola treatments currently under development. The goal is 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
The EMA has launched a pilot project to involve patients ion the assessment of the benefits and risks of medicines in CHMP meetings.
More information on all outcomes of the CHMP’s September 2014 meeting is available on the EMA’s webpages, or here.
