FDA approval for Pitolisant tablets
The US FDA has granted final approval to Lupin's Abbreviated New Drug Application (ANDA) for Pitolisant tablets, 4.45 mg and 17.8 mg, recognising the product as bioequivalent to the reference brand Wakix.
The approval adds another generic offering to Lupin's expanding US portfolio.
Strategic partnership to bring YUVEZZI to Europe
Separately, Lupin's wholly owned subsidiary, VISUfarma BV, has entered into an exclusive licensing agreement with Visus Therapeutics, a subsidiary of Tenpoint Therapeutics Holding Limited.
The deal grants VISUfarma exclusive rights to the regulatory activities, commercialisation, marketing and distribution of YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) throughout the European Union, the United Kingdom, Switzerland, Norway and Iceland.
YUVEZZI is described as the first and only approved once-daily, dual-agent eye drop for presbyopia, a condition affecting millions of adults worldwide.
As part of the agreement, VISUfarma will make a strategic investment in Visus, whereas Tenpoint and Visus will receive regulatory and commercial milestone payments plus tiered royalties on net sales.
Lupin CEO Vinita Gupta noted that the deal builds on the company's earlier acquisition of VISUfarma and strengthens its European eye care franchise.
Tenpoint CEO Henric Bjarke pointed to Lupin's established commercial infrastructure and VISUfarma's ophthalmology expertise as key advantages for bringing the therapy to European patients.
Tenpoint is already progressing YUVEZZI's commercialisation in the US following FDA approval there and has submitted a Marketing Authorisation Application in the UK via the MHRA's International Recognition Procedure.
