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

September 30, 2023

AstraZeneca received approval from CDSCO for palivizumab to prevent RSV infection.

AstraZeneca approved palivizumab, a preventive therapy for Respiratory Syncytial Virus (RSV), by the Central Drugs Standard Control Organisation (CDSCO). The company has received marketing approval to import and distribute palivizumab injection 100 mg/ml (rDNA origin) in India, which is available in single-dose vials for intramuscular administration, with presentations of 50mg/0.5mL and 100 mg/mL.

This therapy is recommended for the prevention of severe lower respiratory tract diseases caused by RSV in children at high risk for RSV-related illness, including:

1. Infants born at 35 weeks of gestation or less who are under six months old at the beginning of the RSV season.

2. Children under two years of age who have been treated for bronchopulmonary dysplasia (BPD) within the last six months.

3. Children under two years of age with significant congenital heart disease (CHD) requiring medical attention.

RSV poses a significant public health challenge worldwide, particularly in children. It ranks as the second leading cause of death in children under one year, second only to malaria. According to the WHO, RSV is responsible for over 60% of acute respiratory infections in children and, over 80% in infants under one year old. The disease accounts for nearly 50% of pneumonia cases and up to 90% of infant bronchiolitis cases. In India, RSV is the primary cause of hospitalization in children under one-year-old.

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.