FDA speeds approval for Sucraid Oral Solution
ROCKVILLE, Md. The Food and Drug Administration sped up the approval process to allowing changes in the manufacturing of a treatment for congenital sucrase-isomaltase deficiency, the agency said in a statement Thursday.
The drug, Sucraid Oral Solution, made by QOL Medical, has been prescribed for about 400 patients with CSID. The disease results in a lack of the enzyme sucrase, which the body needs to process the sugar sucrose. Symptoms of the disease include diarrhea, abdominal pain and severe cramping when eating foods that contain the sugar. It is common among Alaska Natives and people of Nordic descent.
“The FDA has expedited its approval of the newly manufactured Sucraid,” said Julie Beitz, director of the FDA Center for Drug Evaluation and Research’s Office of Drug Evaluation III. “However, the manufacturing changes could lead to more frequent allergic reactions. To continue our rigorous oversight, FDA is requiring the manufacturer to inform prescribers and patients of the changes and conduct a post-marketing study.”
The FDA approved the drug, known generically as sacrosidase, in 1998.
Amgen, Takeda cancer drug trials stopped after deaths
NEW YORK Several deaths have brought phase 3 clinical trials of a cancer drug by Amgen and Takeda Pharmaceutical to a halt.
The two companies are investigating the drug, motesanib, as an initial treatment for small-cell lung cancer, to be used in conjunction with chemotherapy.
A committee monitoring the 600-patient study found more had died early using the drug than those receiving placebo.
“While we are disappointed in the outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,” Amgen executive vice president for research and development Roger Perlmutter said in a statement.
Elan appoints Paya as president
SOUTH SAN FRANCISCO, Calif. Elan Corp. has appointed Carlos Paya as president, the company announced Thursday.
Paya will work from Elan?s South San Francisco, Calif., campus, focusing on leading the company’s scientific, clinical and medical initiatives.
“As an immunologist, a former vice dean of clinical investigation at the Mayo Clinic and as a successful industry executive, Dr. Paya has a unique set of attributes and experiences that perfectly match the opportunities and challenges facing Elan,” said Elan chairman of the board Kyran McLaughlin in a statement.
Paya previously worked at Eli Lilly & Co. as vice president of Lilly Research Labs and global leader of the Diabetes and Endocrine Platform. He had served as an executive at Lilly since 2001. He also worked for six years at the Mayo Clinic as professor of medicine, immunology and pathology, in addition to his position as vice dean.