Novartis (NYSE:NVS)
Scemblix (asciminib) is developed by Novartis (NYSE:NVS) and recently received EC approval for the treatment of adults with chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have been treated with two or more tyrosine kinase inhibitors (TKIs).
Scemblix nearly quadrupled the primary molecular response rate compared to Bosulif (bosutinib), and the discontinuation rate due to adverse effects was more than three times lower at 24 weeks and confirmed at 96 weeks; therefore, these results were used to justify the approval.
In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion, signaling that approval was imminent.
Scemblix, it is claimed, is the first medication for CML to work as a STAMP inhibitor, meaning it targets the ABL myristoyl pocket.
For adults with Ph+ CML-CP who had previously been treated with two or more TKIs based on MMR rate at 24 weeks, the FDA awarded accelerated clearance for Scemblix last year, and full approval was granted for adults with Ph+ CML-CP who had the T315I mutation. The FDA is reviewing the 96-week data Novartis (NYSE:NVS) submitted, which focuses on the drug’s efficacy and safety in the longer term.
Scemblix is now being researched as a monotherapy and in conjunction with other treatments for CML-CP.
Compared to the industry’s 2.6% fall this year, Novartis (NYSE:NVS) shares are down 6%.
Novartis’s (NYSE:NVS) already robust oncology portfolio will be bolstered by its approval. The clearance of new pharmaceuticals is also encouraging for Novartis, which is working to fortify its core pharmaceutical business by spinning out Sandoz, its generics and biosimilars subsidiary, into a new publicly traded standalone company.
Novartis (NYSE:NVS) stated that they would be conducting a review of their Sandoz division’s strategic direction in October of that year. Sandoz’s sales and profitability plummeted, especially in the United States, owing to price competition among generic pharmaceutical producers and buyer consolidation.
The company’s Alcon eye care branch was previously split off into its own entity.
Novartis (NYSE:NVS) plans to achieve a balanced geographic footprint while bolstering its position in its five core therapeutic areas (hematology, solid tumors, immunology, neuroscience, and cardiology) and technology platforms (gene therapy, cell therapy, radioligand therapy, targeted protein degradation, and xRNA).
Featured Image: Megapixl @Doityourself13
Author Shariq Khan 
