Manufacturing Concerns Halt US Approval for Novo Nordisk's Factor XIII

By Dan Stanton

- Last updated on GMT

Related tags Novo nordisk Growth hormone

Approved in Europe but second CRL for Novo Nordisk's rare bleeding disease therapy
Approved in Europe but second CRL for Novo Nordisk's rare bleeding disease therapy
Novo Nordisk says it has received a complete response letter for its recombinant factor XIII drug citing manufacturing concerns at a Danish facility.

The complete response letter (CRL) was sent to Novo Nordisk in June, the company revealed in last week’s 2013 interim results, and is the second CRL the firm has received for the treatment of congenital factor XIII deficiency, a rare type of bleeding disease.

Mike Rulis, a spokesperson from Novo Nordisk, told Biopharma-Reporter that the CRL was received “on June 27 and the findings in question concern a manufacturing facility in Denmark.”

Though he declined to divulge further details of the problems, he did add: “We are working with the agency to address the issues, and pending resolution hereof we will resubmit the file. The CRL has no implications for Novo Nordisk’s biologics strategy going forward.”

A transcript​ of a conference call discussing the results, also showed the firm is awaiting the “finalization of some outstanding issues surrounding the inspection of the manufacturing facilities,”​ according to Mads Krogsgaard Thomsen – CSO and Executive VP at Novo Nordisk.

He also said the company has removed from the drug application its add-on indication to treat ulcerative colitis as “it seems as if there's no relationship between factor XIII levels in the patients and their degree of ulcerative colitis.”

Recombinant Factor XIII was licensed to Novo Nordisk from ZymoGenetics and is an alternative to receiving blood transfusions for sufferers of factor XIII deficiency, a rare bleeding disorder affecting approximately 900 patients globally, according to the firm.

The drug contains the active substance catridecacog produced in yeast cells by recombinant DNA technology intended for intravenous use.

It has already been launched in Europe under the name NovoThirteen, following positive opinion​ from the Committee for Medicinal Products for Human Use (CHMP) in May 2012.

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