NEWS

FDA Approves Ravicti (Phenylbutyric Acid Glyceride) to Expand Applicable Population

Release time:

2019-01-11 17:04

Horizon Pharma recently announced that the U.S. Food and Drug Administration (FDA) has approved Ravicti(glycerol phenylbutyrate, phenylbutyrate) oral liquid to expand the applicable population, including infants within two months, which was not included in the previous FDA and EC approvals.

Horizon Pharma is a biopharmaceutical company whose main research interests are arthritis and rheumatic diseases, including urea cycle disorders (UCD). It is difficult for UCD patients to exclude N from protein in the form of urea, so a large amount of ammonia will accumulate in the body after eating protein, which will eventually cause irreversible brain damage and even death. For this congenital disease, it is of great significance to expand the applicable population to infants within two months.

The approved Ravicti will be delivered to the audience in the form of an oral solution for use with dietary protein restrictions and, in some cases, must also be used with dietary supplements (e. g. essential amino acids, arginine, citrulline, protein-free caloric supplements).

There are as many as 11 U.S. patents related to Ravicti, and many of them are in litigation, which to some extent illustrates the huge commercial value of the orphan drug.

Related Patent Information

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