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FDA starts review of Novo's refiled diabetes pair

Tresiba and Ryzodeg were rejected in 2013

Novo Nordisk headquarters 

The US FDA has started a fresh review of Novo Nordisk's long-acting insulin therapies Tresiba and Ryzodeg, which it turned down two years ago.

The clock is now ticking for a possible decision in October and launch before the end of the year for the two drugs, which if approved will enter a market currently dominated by Sanofi's $7bn basal insulin blockbuster Lantus (insulin glargine).

Tresiba (insulin degludec) and combination product Ryzodeg (insulin degludec and insulin aspart) were rejected by the FDA in 2013 - against the advice of its own expert panel - because the regulator wanted additional data on cardiovascular safety.

Novo Nordisk refiled its marketing applications for the two products last month based on interim results from the 7,600-patient DEVOTE trial, which is not due to complete until 2016 and to generate final follow-up data until 2018.

"To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data," said the pharma company in a statement.

"This team has prepared the interim analysis for the … resubmission and will interact with the FDA during the review, on matters related to the interim analysis."

The FDA's decision to start the review based on that dataset is a massive boost for the Danish drugmaker as it could allow the two drugs onto the market before Sanofi's Lantus follow-up Toujeo gets established in the market. Toujeo has been cleared in the US and recommended for approval by the EMA's Committee for Medicinal Products for Human Use (CHMP).

The entire market for basal insulins is set for a shake-up once biosimilar versions of Lantus reach the market - potentially within the next few months - so both Novo Nordisk and Sanofi will likely be trying to capture market share in the face of significant headwinds and downward pressure on pricing.

Eli Lilly and Boehringer Ingelheim have tentative approval in the US for their biosimilar version of Lantus - which has been given a green light in Europe - and are poised for launch once Sanofi's patents run out or they win a favourable ruling in the law courts.

Until recently, additional competition was also looming in the form of Lilly's long-acting insulin peglispro, although that project has now been significantly delayed after fatty liver changes were seen in patients receiving the drug in clinical trials.

Analysts had been predicting that Tresiba and Ryzodeg could collectively achieve peak annual sales of $4bn ahead of the FDA rejection in 2013, and while those expectations have been scaled down in the interim some still believe $2bn a year is feasible.

Article by
Phil Taylor

9th April 2015

From: Sales

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