Related Jobs
-
Technical Manager, Regulatory Affairs Development
Job Type: Permanent
Salary: Salary on application
Location: Belgium -
Director Regulatory Affairs
Job Type: Permanent
Salary: Excellent salary
Location: Switzerland
Expanded EU diabetes drug application withdrawn
16 Oct 2006
Regulatory Affairs
Novo Nordisk, a Danish firm with UK representation in West Sussex, has withdrawn an application to the European Medicines Agency (EMEA) to expand the treatment authorisations on two drugs.
NovoNorm (repaglinide) and Prandin (repaglinide) have both received regulatory approval previously in the EU to be used in combination with exercise and diet management, and alongside the diabetes drug metformin, to treat patients with type two diabetes.
The expanded application looked for approval for the two drugs to be used alongside thiazolidinediones, a common class of anti-diabetic treatments.
"Following review of the data submitted, the agency's Committee for Medicinal Products for Human Use had some concerns and was of the provisional opinion that NovoNorm or Prandin in combination with a thiazolidinedione could not be approved," said a press released from the EMEA.
"In its official letter, the company stated that the reason for withdrawing was the committee's consideration that the data provided did not allow it to conclude on a positive benefit-risk balance of the concomitant use of repaglinide and thiazolidinediones," added the agency's statement.
The company has, at time of writing, not yet issued its own press release concerning the withdrawal.
Shares in the company trading in New York have lost some ground after something of a resurgence in the past fortnight.
© Adfero Ltd
