MANKIND PHARMA | MedPath

NPPA Sets Retail Prices for 84 Drugs Including Empagliflozin Combinations Following Patent Expiry

15 days ago

• India's National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 84 new drug formulations, including 36 combinations containing the recently off-patent diabetes medication empagliflozin. • The price regulations follow the March 11, 2025 expiry of Boehringer Ingelheim's empagliflozin patent, opening the market to multiple pharmaceutical companies including Mankind Pharma, Lupin, and Alkem Laboratories. • Beyond diabetes medications, the NPPA's pricing decisions also cover anti-hypertensive combinations containing telmisartan and metoprolol, as well as anti-inflammatory formulations with paracetamol and mefenamic acid.

CDSCO Panel Rejects Phase III Trial Waivers for Resmetirom in India, Approves Bioequivalence Studies

2 months ago

• India's CDSCO expert committee has rejected Phase III clinical trial waivers for Resmetirom tablets proposed by both Morepen Laboratories and Mankind Pharma, requiring local clinical data before marketing approval. • Resmetirom, a thyroid hormone receptor-β agonist recently approved for treating noncirrhotic NASH with moderate to advanced liver fibrosis, works by regulating lipid metabolism and reducing liver fat. • The regulatory panel has granted permission for bioequivalence studies to proceed while requesting additional clinical data, particularly from Indian and Southeast Asian populations.

Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors

2 months ago

• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes. • As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage. • Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.

Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost

2 months ago

• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. • Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. • The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.

Mankind Pharma Advances Novel Oral Anti-Obesity Drug in Phase 2 Trials

3 months ago

• Mankind Pharma has developed a pioneering GPR109 agonist as the world's first potential small-molecule oral treatment for obesity, currently advancing through Phase 2 trials in Australia. • The innovative drug offers advantages over existing injectable peptide treatments like Wegovy and Mounjaro, requiring no food-related restrictions and providing a more convenient oral administration route. • Phase 1 results have shown promising outcomes, with Phase 2 trial results expected by the end of the year, positioning Mankind Pharma for a potential breakthrough in the global obesity treatment market.

FDA Tightens Requirements for China-Developed Drugs, Mandates Multi-Regional Trials

3 months ago

• The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. • At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. • The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.

Weight Loss Drug Race Heats Up: Zepbound Outperforms Wegovy, New Therapies Target Muscle Growth

6 months ago

• Eli Lilly's Zepbound demonstrated superior weight loss compared to Novo Nordisk's Wegovy in a head-to-head trial, with Zepbound users losing over 20% of body weight versus Wegovy's under 14%. • Several companies, including Eli Lilly, Regeneron, and Veru, are developing new weight loss drugs that aim to preserve or promote muscle growth, addressing concerns about muscle loss with existing GLP-1 therapies. • The obesity treatment market is experiencing rapid growth and innovation, with over 300 GLP-1R drugs in development and analysts projecting sales to potentially reach $150 billion annually by the early 2030s. • Upcoming trial readouts in 2025 from companies like Metsera, Skye Bioscience, and Eli Lilly may introduce novel mechanisms and improved convenience, further intensifying competition in the obesity market.