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India new drug approvals | 2023 | CDSCO | Ministry of health news | iPharmaCenter

Sun Pharma and Pharmazz Inc. have joined forces through a licensing agreement to introduce sovateltide, marketed as Tyvalzi (sovateltide), in India. Tyvalzi (sovateltide) is a groundbreaking drug designed to address acute cerebral ischemic stroke, with the unique capability of being administered up to 24 hours after the onset of symptoms. This marks a significant milestone as India becomes the inaugural global territory for introducing Tyvalzi (sovateltide).

Sun Pharma, a prominent pharmaceutical company, recently announced that one of its wholly-owned subsidiaries has inked a licensing deal with Pharmazz Inc., a biopharmaceutical company based in the United States. This agreement aims to commercialize Tyvalzi (sovateltide), an innovative and first-of-its-kind drug developed by Pharmazz for potential global use in the treatment of cerebral ischemic stroke.

Under the terms of this agreement, Sun Pharma has been granted the rights to market Sovateltide in India under the brand name Tyvalzi (sovateltide). Pharmazz will receive upfront payments, milestone payments, and royalties as part of this collaboration.

The gravity of the issue is underscored by the statistics related to stroke in India. According to a report, India witnessed a staggering 1,175,778 incident cases of stroke. Research conducted in India has shown that the occurrence of stroke varies from 116 to 163 cases per 100,000 individuals in the population. This medical condition poses a substantial public health challenge, as it stands as the fourth leading cause of mortality within India.

Alarmingly, projections indicate that by 2050, more than 80% of the predicted global burden of new strokes, totalling 15 million cases, will occur in low and middle-income countries, including India.

It's important to note that Sun Pharmaceutical holds ownership rights to the brand name Tyvalzi, solidifying its role in bringing this groundbreaking treatment to the Indian market.

Sanofi Healthcare has recently obtained marketing authorization for Dupixent (dupilumab) in India. Dupixent is a biologic approved for treating moderate-to-severe atopic dermatitis in adults who either have insufficient control with topical prescription therapies or for whom these therapies are unsuitable. The medication can be used alone or in combination with topical treatments.

Globally, Dupixent acts in patients suffering from atopic dermatitis by explicitly targeting the type 2 inflammation that underlies the disease without broadly suppressing the immune system. Atopic dermatitis, a type 2 inflammatory disease and a form of eczema presents with skin rash as a common symptom. Moderate-to-severe cases are characterized by widespread rashes covering much of the body and intense, persistent itching, skin dryness, redness, crusting, and oozing.

With over 600,000 patients worldwide benefiting from Dupixent, this medication will soon be available as a viable option for managing moderate to severe atopic dermatitis in adult patients in India.

The development of Dupilumab is a collaborative effort between Sanofi and Regeneron, working together under a global collaboration agreement.

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