Two new diabetes drugs to be reviewed by FDA next week
NEW YORK The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee will review two new diabetes drugs next week, and this has left investors nervous, according to published reports.
On April 1, the committee will review Onglyza (saxagliptin), by AstraZeneca and Bristol-Myers Squibb, and review Victoza (liraglutide) the next day. According to Reuters, however, an FDA rejection earlier this month of Takeda Pharmaceutical’s alogliptin calling for additional clinical data, caused the company’s stock to fall.
According to the news agency, an analyst said that the FDA might be slow to approve drugs similar to those on the market. Onglyza is a DPP-4 inhibitor, belonging to the same class as alogliptin; Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin) is already on the market.
Study: Children with autism may benefit from hyperbaric therapy
MELBOURNE, Fla. Children with autism may benefit from time spent in a hyperbaric chamber, according to a new study.
The randomized, controlled and double-blind study, published in the journal BMC Pediatrics and titled “Hyperbaric treatment for children with autism,” found that children who were placed in an OxyHealth portable hyperbaric chamber and breathed 24% oxygen at a pressure 1.3 times that of the atmosphere for 40 hourly sessions had significant improvements in overall functioning, social interaction and other areas, compared with children who received slightly pressurized room air.
“In our study, we observed significant improvements in several core autistic behaviors with the use of hyperbaric therapy at [1.3 atmospheres] compared to children receiving near-placebo treatment,” physician and lead study author Daniel Rossignol said in a statement. “These findings confirm what we are seeing in clinical practice – that many children with autism may benefit with the use of this treatment.”
Perrigo receives FDA approval for topical acne treatment
ALLEGAN, Mich. The Food and Drug Administration has approved a new drug from Perrigo Co., the generic and OTC drug maker announced Tuesday.
The FDA approved Perrigo’s sulfacetamide sodium topical suspension in the 10% strength. The lotion is a generic version of Sanofi-Aventis’ Klaron and is used to treat acne.
Klaron had sales of $15 million for the 12-month period ending in January, according to Wolters Kluwer Health data.