Lupin Limited receives U.S. FDA approval and updates insulin trials

Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The FDA has deemed these tablets bioequivalent to Wakix.

In India, the Subject Expert Committee under the Central Drugs Standard Control Organisation (CDSCO) has requested that Lupin revise its proposed Phase III clinical trial protocol for its biosimilar Insulin Degludec injection. The recommendation follows the company's presentation of Phase I pharmacokinetic/pharmacodynamic study results. The proposed trial aims to establish the non-inferiority of Lupin’s biosimilar insulin to the reference product, Tresiba, for the treatment of Type 2 diabetes mellitus.