Well being Canada approves Santhera’s Agamree for DMD remedy
Well being Canada has accepted Santhera Prescription drugs’ Agamree (vamorolone) to deal with Duchenne muscular dystrophy (DMD) in people aged 4 years and above.
Agamree is the primary accepted remedy for DMD within the nation.
Uncover B2B Advertising That Performs
Mix enterprise intelligence and editorial excellence to achieve engaged professionals throughout 36 main media platforms.
The choice follows a precedence assessment and is supported by the Section IIb VISION-DMD trial knowledge, together with security knowledge from 4 open-label trials, together with extensions.
The research evaluated the drug at doses between 2 to six mg/kg/day over intervals as much as 48 months.
Agamree’s efficacy was on par with conventional corticosteroids, however with fewer adversarial results, notably concerning bone well being, progress and behavior.
In July 2024, Kye Prescription drugs secured unique business rights for Agamree in Canada, following a sub-licence settlement with Santhera’s commercialisation associate, Catalyst Prescription drugs.
Kye Prescription drugs president and CEO John McKendry acknowledged: “This Well being Canada approval displays Kye Prescription drugs’ dedication to advancing therapies for uncommon ailments and serving the unmet wants of Canadian sufferers.
“We stay dedicated to working alongside the DMD group and with provincial drug plans and personal insurers throughout Canada to make sure Agamree is accessible to people dwelling with DMD.”
Santhera will acquire royalties from Canadian gross sales, which can even contribute to the gross sales milestones from Catalyst for the North American market.
The corporate has out-licensed the drug’s rights to Sperogenix Therapeutics for the Chinese language market and sure Southeast Asian international locations.
Throughout VISION-DMD, the drug met the first purpose by demonstrating an enchancment within the time to face velocity after 24 weeks of remedy when in comparison with a placebo, together with a beneficial tolerability and security profile.
Santhera’s focus is on creating and commercialising therapies for uncommon neuromuscular circumstances that lack sufficient medical options.
It holds an unique world licence from ReveraGen for all indications associated to Agamree.
The US Meals and Drug Administration, China’s Nationwide Medical Merchandise Administration, Hong Kong’s Division of Well being, the European Fee and the UK Medicines and Healthcare merchandise Regulatory Company additionally accepted Agamree for DMD remedy.
Santhera beforehand signed an unique settlement with Ikris Pharma Community to distribute Agamree in India.
Join our every day information round-up!
Give your online business an edge with our main trade insights.
