Biodel’s Ultra-Rapid-Acting Insulin Linjeta Faces Significant Setbacks in its Path to Regulatory Approval in the United States

In unfortunate news, Biodel’s ultra-rapid-acting insulin Linjeta (formerly known as VIAJect; see Learning Curve in diaTribe #9 and Conference Pearls in diaTribe #26) recently failed to receive FDA approval. The FDA has requested for Biodel to conduct two additional phase 3 studies for Linjeta to better characterize its efficacy, tolerability, and stability. Biodel is now weighing its options, deciding whether to conduct the studies or to start again with one of its newer formulations of Linjeta, which should have better tolerability, comparable drug properties (e.g. rate of absorption, duration of effect), and comparable effects of the drug on the body. (The newer formulations use the same ingredients as Linjeta, just in different amounts.) What this means is that it will most likely take until at least 2012 for Linjeta or another one of Biodel’s ultra-rapid-acting insulin candidates to get approved and come to market, assuming a favorable review.

Since the need for faster-acting insulins is urgent, we are saddened by these developments.  Looking ahead, the FDA will give its decision on Afrezza, MannKind’s ultra-rapid-acting inhalable insulin, on December 29. Further down the road, we hope to see progress with Halozyme Therapeutics’ PH20, a therapy currently in phase 2 studies that aims to bring about faster insulin absorption and higher insulin concentrations upon co-administration. There is tremendous interest in faster-acting insulin by patients, doctors, educators, and families and we hope the FDA can work with the companies to help them bring innovation to patients and to make insulin both faster-acting and ultimately even easier to use.  --VW