USFDA approves bleeding disorder therapy

Hemophilia A is a genetic disorder that causes a missing or defective factor VIII clotting protein.

127
USFDA Approval
USFDA Approval

Last Updated on October 9, 2024 by The Health Master

New Delhi: Sanofi’s Altuviiio has gained approval from the U.S. Food and Drug Administration (USFDA) for the treatment of hemophilia A, a type of inherited bleeding disorder.

The French drugmaker is set to launch the therapy in the United States in April, entering a market where factor replacement therapies have been the standard treatment for decades.

Altuviiio: A Potential Best-in-Class Therapy

Factor replacement therapies have been used to replace the missing blood clotting factor and allow blood to clot properly by injecting treatment products into a patient’s vein.

With Sanofi’s new drug, Altuviiio, the company is expected to enter the market with one of the best-in-class therapies, according to Damien Conover, a Morningstar analyst. Barclays analyst Emily Field also predicts global peak sales of €2.3 billion.

Pricing and Competition

Currently, the average annual cost of clotting factor therapies is around $300,000. Sanofi is expected to price Altuviiio slightly higher than traditional factor therapies, with the drug priced at parity to the annual cost of treating a prophylaxis patient on Eloctate.

The French drugmaker gained access to Eloctate and Altuviiio through the $11.6 billion acquisition of U.S. hemophilia specialist Bioverativ in 2018.

Altuviiio’s approval also offers patients an alternative to Roche’s Hemlibra, which is the current market leader for this indication.

However, it is anticipated that Altuviiio will only take share from other factor therapies and not from Hemlibra in the first few years following its launch, according to Field.

Conclusion

Hemophilia A is a genetic disorder that causes a missing or defective factor VIII clotting protein.

Sanofi’s Altuviiio is now a viable treatment option for those with this condition and is expected to make a significant impact on the market.

With its potential as a best-in-class therapy, Sanofi is poised to make a strong entrance into the competitive world of hemophilia A treatment.

USFDA issues EIR to Strides for Bangalore facility

Hyderabad is having maximum USFDA approved Pharma Units in world

USFDA gives tentative nod for Gabapentin Tablets, 300 mg and 600 mg

USFDA gives approval for Saxagliptin Tablets 2.5 mg and 5 mg

USFDA gives tentative nod for these two generic drugs

USFDA gives nod for Aflibercept injection to treat infants with prematurity issue

Govt firm on Ban of online sale of medicines

‘Chintan Shivir’ to be held with focus on Drug Quality Regulation and Enforcement

Kerala cracks down on violators of Cosmetic Rules

USFDA issues EIR to Strides for Bangalore facility

Govt taking steps to boost high value Pharmaceuticals and Medical Devices

Punjab to write to Centre Govt to regulate prices of Non Scheduled medicines

NLEM: Essential drugs list to be amended soon by including these products

Drug alert: 67 out of 1348 samples declared as NSQ in January 2023

New DCGI: Rajeev Raghuvanshi appointed head of apex drug regulatory body

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news