Indian pharmaceutical company Beta Drugs Ltd (BDL) has received approval from the Drugs Controller General of India (DCGI) for azacitidine oral, a New Drug Delivery System (NDDS) formulation of azacitidine injection, according to Economic Times.
The company is introducing the new breakthrough drug, under the brand name MDS-O, at an affordable price. It aims to increase accessibility to Indian patients, ensuring drug compliance among patients with acute myeloid leukemia (AML).
The U.S. Food and Drug Administration (FDA) approved azacitidine injection for AML treatment in May 2004. Celgene Corporation, a subsidiary of Bristol Myers Squibb, received the approval of azacitidine injection, which is sold under the brand name Vidaza.
Azacitidine is the only drug that improves the overall survival rate of adult patients with AML. It is also used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells, according to WebMD.
Earlier, BDL had brought a paradigm change in the treatment of MDS, launching the brand MDS (azacitidine injectable). And now, it has received approval for MDS-O, another progressive breakthrough in the treatment of AML.
Azacitidine oral has huge scope in the Indian market considering the high incidence rate of AML. Plus, the drug ensures a survival advantage, compared with existing chemotherapy drugs.
BDL is strengthening its presence in the Indian drug market, as it is expected to introduce a generic version of Pazopanib and Afatinib.
The company ensures the quality and affordability of its oncology drugs due to its ability to produce in-house active pharmaceutical ingredients (APIs). Other pharma companies that develop generic azacitidine injectable include Accord Healthcare, Actavis, Cipla, Dr. Reddy’s, Eurohealth, Meitheal, Mylan, and Natco Pharma.