Date: 2017-09-14
Type of information: Refusal of a Market Autorisation in the EU
Product name: Adlumiz®
Compound: anamorelin
Therapeutic area: Cancer - Oncology
Action mechanism:
Company: Helsinn Group (Switzerland)
Disease: anorexia, cachexia, or unintended weight loss in non-small cell lung cancer (NSCLC) patients
Latest news:
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• On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) confirmed the refusal of the marketing authorisation.
• On June 22, 2017, the Committee for Medicinal Products for Human Use (CHMP) announced that Helsinn has requested a re-examination of the CHMP’s May 2017 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.
- • On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Adlumiz®, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer. The company that applied for authorisation is Helsinn Birex Pharmaceuticals. It may request a reexamination
of the opinion within 15 days of receipt of notification of this negative opinion.
- • On November 30, 2015, Helsinn announced that the European Medicines Agency (EMA) accepted for review, the marketing authorization application (MAA) for anamorelin HCI, a novel, orally active selective ghrelin receptor agonist under development for the treatment of anorexia, cachexia, or unintended weight loss in non-small cell lung cancer (NSCLC) patients.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
