FDA extends review of Novo Nordisk's diabetes therapies Tresiba, Ryzodeg
(Ref: Chicago Tribune, Novo Nordisk)
June 8th, 2012
By: Matthew Dennis
Novo Nordisk reported Friday that the FDA extended its review period for the ultra-long-acting insulin Tresiba (insulin degludec) and insulin combination analogue Ryzodeg (insulin degludec/insulin aspart) by three months. The company, which submitted the regulatory filings for the diabetes therapies in September last year, revealed that the agency asked for further data clarification and analyses.
The drugmaker noted that it provided a substantial amount of additional data to the FDA, which "due to the size and timing of these submissions" have been deemed by the regulator as major amendments to the marketing applications. Novo Nordisk added that the agency hasn't requested additional clinical trials for the drugs. The FDA is now expected to make a decision on the applications by October 29.
In response to the news, analysts at Danske Bank said that a US launch of the products in 2012 now seemed unlikely but they did not believe the likelihood of approval had decreased. Deutsche Bank analyst Tim Race added "we see the delay as unexpected and disappointing, but ultimately not unusual," noting that it would have limited financial implications for the company.
Novo Nordisk has also filed for approval of Tresiba and Ryzodeg in Europe, Japan, Canada, Switzerland and other markets.
(Ref: Chicago Tribune, Novo Nordisk)
June 8th, 2012
By: Matthew Dennis
Novo Nordisk reported Friday that the FDA extended its review period for the ultra-long-acting insulin Tresiba (insulin degludec) and insulin combination analogue Ryzodeg (insulin degludec/insulin aspart) by three months. The company, which submitted the regulatory filings for the diabetes therapies in September last year, revealed that the agency asked for further data clarification and analyses.
The drugmaker noted that it provided a substantial amount of additional data to the FDA, which "due to the size and timing of these submissions" have been deemed by the regulator as major amendments to the marketing applications. Novo Nordisk added that the agency hasn't requested additional clinical trials for the drugs. The FDA is now expected to make a decision on the applications by October 29.
In response to the news, analysts at Danske Bank said that a US launch of the products in 2012 now seemed unlikely but they did not believe the likelihood of approval had decreased. Deutsche Bank analyst Tim Race added "we see the delay as unexpected and disappointing, but ultimately not unusual," noting that it would have limited financial implications for the company.
Novo Nordisk has also filed for approval of Tresiba and Ryzodeg in Europe, Japan, Canada, Switzerland and other markets.