Sector News

Sanofi’s Altuviiio receives FDA approval to treat haemophilia A

February 25, 2023
Life sciences

Sanofi has received approval from the US Food and Drug Administration (FDA) for its Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], to treat a type of inherited bleeding disorder known as haemophilia A.

Altuviiio, previously referred to as efanesoctocog alfa, is indicated for routine prophylaxis and on-demand treatment for controlling bleeding episodes and perioperative management (surgery) for haemophilia A adults and children.

It is a new von Willebrand Factor (VWF) independent recombinant factor VIII therapy which is intended to extend protection from bleeds with once-a-week prophylactic dosing for indicated adults and children.

The therapy is claimed to be the first and only haemophilia A treatment that provides normal to near-normal factor activity levels (over 40%) with once-a-week dosing for most of the week.

It is expected to be available commercially in April in the US.

Sanofi CEO Paul Hudson said: “Today’s approval of ALTUVIIIO allows patients and physicians to reimagine living with haemophilia.

“The high sustained factor activity levels that can be achieved with ALTUVIIIO have the potential to change the haemophilia landscape.

“Significant shifts in treatment paradigms that improve people’s lives, like ALTUVIIIO, are what we have committed to delivering at Sanofi.”

The regulatory approval is supported by the data obtained from the pivotal Phase III XTEND-1 trial.

The trial evaluated the pharmacokinetics, efficacy, and safety of once-a-week ALTUVIIIO in people aged 12 years or above living with severe haemophilia A.

Earlier, they received treatment with factor VIII replacement therapy.

Findings showed that once-a-week ALTUVIIIO prophylaxis met the primary endpoint and offered significant bleed protection for severe haemophilia A patients with 0.70 means annualised bleeding rate (ABR) and 0.0 median ABR.


comments closed

Related News

March 19, 2023

Ferring Pharmaceuticals’ 1st in class C.diff Treatment, Rebyota, experiences a positive early launch ahead of potential competition

Life sciences

With a first to market advantage, Ferring’s Rebyota has seen early positive adoption from gastroenterologists and infectious disease specialist in the first month post-launch. As part of their Launch Dynamix™: C.diff service, Spherix reports, while new monthly initiations are modest, a majority of physicians trialing Rebyota report high satisfaction.

March 19, 2023

UCB enters drug discovery collaboration with Aitia

Life sciences

Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder.

March 19, 2023

Novo, Medtronic add $25M in fuel to FIRE1 and its heart failure monitoring device

Life sciences

Foundry Innovation & Research 1—known by its much catchier acronym, FIRE1—announced Wednesday the close of a $25 million financing round. It was led by a pair of new investors in the company: Andera Partners and Novo Holdings, the holding and investment company that serves as the controlling shareholder for Novo Nordisk and Novozymes.

How can we help you?

We're easy to reach