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Novo Nordisk's long-acting haemophilia B drug cleared by FDA

US approval sets up marketing battle with Bioverativ and CSL Behring

Novo Nordisk

Novo Nordisk has claimed US approval for Rebinyn, its long-acting Factor IX for haemophilia B, setting up a marketing battle with Bioverativ's Alprolix and CSL Behring's Idelvion.

Bioverativ and CSL Behring - a member of the CSL group of companies -  will still have a few months before its rival hits the market, however Novo has said it will not launch Rebinyn (nonacog beta pegol or N9-GP) in the US until the first half of next year. The drug was recommended for approval in Europe - where it will be sold as Refixia - in March.

Rebinyn has been cleared by the FDA for on-demand treatment and control of bleeding episodes and the preoperative management of bleeding around the time of surgery in adults and children with haemophilia B.

The FDA's review was based on data from four trials involving 115 patients, and the green light follows a positive vote by the regulator's Blood Products Advisory Committee meeting in April. Rebinyn has a half-life in the body around five times that of older Factor IX drugs such as Pfizer's BeneFix, cutting the number of infusions needed to control bleeds.

Alprolix (eftrenonacog alfa) has been on the US market since 2014 and made $334m for Biogen last year - up more than 40% on 2015 - before the drug was spun out into blood disorder specialist Bioverativ in February. Bioverativ said it booked $86m from the product in the first quarter while Biogen recorded sales of $26m.

Meanwhile Idelvion (albutrepenonacog alfa) was approved in the US in March 2016 - getting EU approval two months later and the nod in Japan in September - and while the Melbourne, Australian-based company does not divulge sales results, it is expected to make a strong showing thanks to dosing every two weeks versus every seven to 10 days for Alprolix.

Novo says Rebinyn will enter the market with a half-life that is superior to Alprolix and around the same as Idelvion, but that will have higher drug exposure throughout the dosing interval.

"We are excited about the approval of Rebinyn in the US, and we consider it an important expansion of the treatment options for patients with haemophilia B," said Novo's chief science officer Mads Krogsgaard Thomsen.

"We are confident that Rebinyn will become an important tool for physicians to help patients manage their bleeds."

The US approval is the second piece of positive news for Novo in a week, after it filed new data to the FDA showing its long-acting insulin Tresiba is less likely to cause low blood sugar levels or hypoglycaemia in patients with type 2 diabetes compared to Sanofi's Lantus.

Article by
Phil Taylor

1st June 2017

From: Regulatory



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