Gaining US Food and Drug Administration (FDA) approval for its news generalized myasthenia gravis (gMG) drug was positive news for Belgium’s largest drug maker UCB (Euronext: UCB), but the company will face challenges, according to sector analytics firm GlobalData.
The approval of Rystiggo (rozanolixizumab-noli), subcutaneouscomes, comes six months after the FDA accepted UCB’s priority review application. It is indicated for both anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibody positive patients diagnosed with generalized MG (gMG). Rystiggo will need an excellent marketing strategy in order to compete in the space, says GlobalData.
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in first-quarter 2024. Rystiggo is expected to become commercially available in the US during the third quarter this year.
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