Enzene Biosciences Romiplostim gets DCGI marketing authorization
Romiplostim, a therapeutic fusion protein, acts as a thrombopoieses stimulating factor, thereby restoring platelet levels and ameliorating the disease.;
New Delhi: Enzene Biosciences Ltd. "Enzene" announced a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.
In doing so, Enzene becomes the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg).
ITP is a rare haematological disorder (prevalently autoimmune) with a primary clinical presentation of aberrantly low platelet levels, and symptoms including an increased bruising and bleeding tendency.
Romiplostim, a therapeutic fusion protein, acts as a thrombopoiesis stimulating factor, thereby restoring platelet levels and ameliorating the disease. As such, it remains one of the most reliable long-term treatment options for ITP patients.
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