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Rystiggo nod brings help for people with rare autoimmune disorder
27-06-2023
A new antibody from Brussels-based UCB (Euronext: UCB) has been approved by the US Food and Drug Administration, for the treatment of certain adults with generalized myasthenia gravis (gMG).
Rystiggo (rozanolixizumab-noli), a FcRN-binding antibody which is administered subcutaneously, will be launched in the third quarter.
The product will compete with argenx’ (Euronext: ARGX) Vyvgart (efgartigimod alfa), another antibody which has the same mechanism of action and which was approved by the US regulator in 2021.
argenx also beat UCB to the punch with the first subcutaneous treatment in this class, the FDA having granted approval for Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) last week.
The FDA nod makes UCB’s option the only treatment in the USA for adults which targets both of the two most common variants of the rare disorder.
More options for gMG
People with gMG can experience a variety of symptoms, including severe muscular weakness that can result in life-threatening respiratory difficulties.
Vera Bril, lead investigator for the pivotal MycarinG trial, said there was “a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG.”
She added: “Rozanolixizumab-noli is a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient-and physician reported outcomes at day 43.”
UCB has invested significantly in this therapy area, with a C5 inhibitor, zilucoplan, also in late-stage development and expected to launch this year should the US and EU regulators give their blessing.
If approved, zilucoplan would become the third therapy of this type on the market, after leading product Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), both marketed by AstraZeneca (LSE: AZN).
The Belgian company acquired rights to the medicine via its $2 billion acquisition of USA-based Ra Pharma in 2018
Other stories of interest
- UCB to present new long-term data for bimekizumab at EULAR 202331-05-2023
- UCB links up with ClearPoint to advance gene therapy drug delivery25-05-2023
- Promise of UCB’s gMG candidates picked up on by journal13-04-2023
- First FDA-approved SC injectable for gMG21-06-2023
- BioSenic puts Phase IIb ALLOB trial on hold19-06-2023
- EC approves Bimzelx for new indications07-06-2023
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