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FDA clears rival diabetes combos from Sanofi and Novo Nordisk

Xultophy set to launch in first half of 2017 while Soliqua is intended for January roll-out

Novo Nordisk's Xultophy and Sanofi's Soliqua are both out of the traps and racing towards the US market, with the FDA clearing the two diabetes combinations on the same day.

Both products include a long-acting basal insulin coupled with a GLP-1 agonist and are intended for the treatment of patients with type 2 diabetes who are not managing their diabetes with either drug used alone.

In the case of Xultophy, the combination is based on Novo's basal insulin Tresiba (insulin degludec) and market-leading GLP-1 agonist Victoza (liraglutide).

In almost a mirror image, Sanofi's Soliqua (variously known as iGlarLixi and LixiLan) combines top-selling basal insulin Lantus (insulin glargine) – albeit now facing biosimilar competition in some markets - and Adlyxin/Lyxumia (lixisenatide).

Sanofi said it intends to move quickly to roll out its product in the US, with a launch slated for January, while Novo Nordisk  is talking about shipping its drug in the first half of 2017.

Both drugs faced advisory committee scrutiny earlier this year - and at the time, analyst Ronny Gal of Bernstein suggested there was little to choose between them in terms of efficacy.

Questions were raised by the panel on whether the convenience of a combination product is offset by reduced flexibility in dosing if their constituents are given separately. That factor – and of course US pricing – could come into play as Sanofi and Novo Nordisk try to convince healthcare payers to stump up for the new products.

Outside the US, Soliqua has been submitted for approval in the EU and several other world markets, and picked up a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) earlier this month. It has not yet been approved in any other market.

Xultophy meanwhile is approved in Europe as IDegLira and sold in six countries to date, although Novo Nordisk has not yet divulged any information on early sales progress. It decided to withhold the product from the German market after failing to get favourable pricing, which will have affected take-up. 

Article by
Phil Taylor

22nd November 2016

From: Regulatory



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