SAN FRANCISCO — Amylin Pharmaceuticals Inc. and Waltham, Mass.-based Alkermes Inc. climbed in Nasdaq trading yesterday after regulators said they do not need more studies for a once-weekly version of the diabetes drug Byetta.
The Food and Drug Administration asked for clarification of manufacturing processes, labeling, and a risk management plan, the companies said. The FDA did not request new tests or information related to quality control violations identified in a December inspection of the plant where the drug is made.
Byetta, a synthetic version of an enzyme derived from the spit of the Gila monster, stimulates pancreas cells to produce the hormone insulin when blood sugar is high in people with Type 2 diabetes. A once-a-week version will appeal to patients and enable the company to generate positive operating cash flow, Amylin’s chief executive, Daniel Bradbury, said in January.
Eli Lilly & Co. markets Byetta outside the United States and co-markets it with Amylin in the United States. The drug was developed by Amylin, and the longer-acting technology was developed by Alkermes.