| |OCTOBER 20258ABBVIE SUBMITS NDA TO FDA FOR TAVAPADON IN PARKINSON'S TREATMENTINDIA TO LAUNCH NOVO NORDISK'S OZEMPIC AMID OBESITY SURGEDanish pharmaceutical giant Novo Nordisk is planning to introduce Ozempic (semaglutide) in India, a once-weekly injectable that was initially approved for type-2 diabetes but is getting recognition as a treatment for obesity and weight management. The launch is following the arrival of Wegovy in June, which is exclusively approved for obesity treatment.The US FDA first gave its approval in 2017 for Ozempic, which made more than 17 billion dollars in sales worldwide last year. In India, it will be go head-to-head with Eli Lilly's Mounjaro, which had sales of 154 crore in the first five months while Wegovy had sales of Rs 19 crore in three months. The introduction of Ozempic is going to stir up competition in India's GLP-1 (glucagon-like peptide-1) market.A Novo Nordisk representative conveyed the importance of India as a major market by saying, "By broadening our semaglutide offerings, we show our determination to providing novel solutions for the expanding burden of chronic illnesses such as diabetes and obesity." Moreover, the company already has the aids of Rybelsus and Wegovy in the market for the GLP-1 therapy in India.Though we don't have details on the price of Ozempic, the release will be before the planned patent expiration, which is in March next year and that will likely give rise to generic versions from local manufacturers like Sun Pharma, Dr Reddy's, Biocon, Cipla, and Zydus Lifesciences.Experts observe that Ozempic is an answer to various problems when it comes to it being a losing weight-related drug as well as the one responsible for reducing cardiovascular and kidney risks which are common complications of diabetes thus making it a safer overall treatment option. POTOP STORIESAbbVie announced that it has officially submitted a NDA to the USFDA for Tavapadon, a next generation selective dopamine D1/D5 receptor partial agonist created to be taken once daily for oral administration for the treatment of Parkinson's disease.The NDA is based on data from the TEMPO clinical development program, which evaluated Tavapadon in a diverse population of persons with Parkinson's disease in monotherapy and adjunctive therapies.In the TEMPO-1 and TEMPO-2 Phase 3 studies in early Parkinson's disease, patients who received Tavapadondemonstrated a statistically significant improvement from baseline on the combined MDS-UPDRS Parts II and III score at Week 26, showing significant improvement in motor fluctuation.Also, the TEMPO-3 study which studied patients taking Tavapadon as an adjunct to levodopa for motor fluctuations with levodopa, demonstrated that the patients experienced more "on time," which is defined as when symptoms were well controlled and there were no troublesome dyskinesia.The NDA submission also includes interim data from TEMPO-4, which is an open-label extension study evaluating the long-term benefit, safety, and tolerability of Tavapadon in patients who continued treatment beyond the randomized studies. AbbVie is submitting the NDA to obtain regulatory approval to provide a new treatment option that might treat both motor symptoms and fluctuations in the treatment of Parkinson's disease.From an industry perspective, if successfully approved, FDA approval of Tavapadon would signify a new mechanism of action in the Parkinson's space and would work to expand AbbVie's footprint in neurology. The regulatory filing is an important milestone, and the regulatory review will be closely followed by clinicians, investors, and patient communities alike. PO
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