Oct 24: Mumbai-based drug maker Glenmark Pharmaceuticals has received approval from the Drug Controller General of India to launch apremilast tablets after conducting clinical trials on psoriasis patients for 16 weeks.
Apremilast was approved in the US for treatment of adults with active psoriatic arthritis and moderate-to-severe plaque psoriasis in 2014. The molecule has been patented by US firm Celgene Corporation in developed markets.
According to the company, apremilast tablets will be launched in India this week and the treatment cost is expected to be Rs 2,000 per month.
Sujesh Vasudevan, president and head of India Formulations and Africa Region at Glenmark said, “Glenmark is proud to be the first player to introduce apremilast, an advanced oral treatment for psoriasis in India. The introduction of this revolutionary treatment will open a new treatment paradigm for millions of patients across the country by overcoming several challenges of the existing therapies”.
Currently, the oral tablets prescribed for moderate-to-severe psoriasis are acitretin, methotrexate, and cyclosporine. Others are biologics such as etanercept, infliximab, adalimumab and secukinumab, which are injectables and even creams are also prescribed generally.
The company also said that apremilast does not have side effects on organs like the liver and the kidneys and that the patient does not need frequent diagnostic tests. Among main brands such as Candid, Candid B, Elovera, Scalpe, Onabet, and Syntran, Glenmark is the number two player in the dermatology market in India.
The company’s strategy for the Indian market is to concentrate on areas of dermatology, respiratory, oncology, cardiology and diabetes and launch new products and build brands in these segments.