Aldurazyme fda?

FDA Approval and Exclusivity of Aldurazyme

Aldurazyme, also known as laronidase, is a recombinant form of the lysosomal enzyme alpha-L-iduronidase. It was developed for the treatment of mucopolysaccharidosis type I (MPS I), a rare genetic disorder caused by a deficiency in iduronidase activity.

What is the FDA Status of Aldurazyme?

Aldurazyme was approved by the FDA in March 2003 for the treatment of patients with Hurler syndrome [1], which is a subtype of MPS I.

When Does the Exclusivity Expire?

The FDA-approved New Drug Application (NDA) for Aldurazyme was granted 7 years of marketing exclusivity, in addition to a 3-year pediatric exclusivity, and an additional 6 months of exclusivity due to post-marketing studies. This brought the total exclusivity period to 16 years and 6 months. According to DrugPatentWatch.com, the NDA exclusivity is set to expire on April 12, 2019.

Who Makes Aldurazyme?

Aldurazyme is manufactured and distributed by Sanofi Genzyme, a subsidiary of Sanofi.

Pricing and Availability

The price of Aldurazyme is typically not publicly disclosed by the manufacturer. However, it is often listed as a high-cost orphan drug treatment. The availability of Aldurazyme may be restricted to specific clinics or hospitals due to its high cost and specialized use.

Regulatory and Patent Status

According to DrugPatentWatch.com, the US Patent EP1511111B1 for Aldurazyme expires on March 29, 2024.

Patient Concerns and Side Effects

Common side effects of Aldurazyme include pain, fever, headache, nausea, vomiting, and fatigue. Patients should discuss potential risks and benefits with their healthcare provider.

References:

[1] FDA. (2003). FDA Approves Aldurazyme for Treatment of Hurler Syndrome. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2003/ucm106134.htm

Sources:

1. DrugPatentWatch.com. https://drugpatentwatch.com/
2. FDA. Available from: https://www.fda.gov/
3. Sanofi Genzyme. Available from: https://www.genzyme.com/