The future for GlaxoSmithKline and Adolor Corp’s investigational bowel drug Entereg looks a little brighter with the news that US regulators have accepted a response from the latter firm to an approvable letter issued on the treatment.
The US Food and Drug Administration has accepted as complete Adolor’s response to a November 2006 New Drug Application approvable letter for Entereg (alvimopan) for the management of postoperative ileus and has set a Prescription Drug User Fee Act goal date of February 10 next year. The two firms have also submitted complete responses to the FDA requesting a release of the clinical holds for all alvimopan Investigational New Drug applications, which is required before the firms can carry on with further development on the compound.
The companies suspended trials of Entereg in April due to cardiovascular risk and two months later, the FDA placed the alvimopan IND applications on clinical hold, including a programme looking at the drug as a treatment for opioid induced bowel dysfunction. Yvonne Greenstreet, senior vice president of the medicines development centre at GSK, said the firm is continuing to work with Adolor and regulatory agencies on both the OBD and POI studies, saying that the firm has “conducted analyses to fully understand the findings from the OBD programme” and these support the request to release the clinical hold.
The response from analysts was welcoming but cautious and Cowen & Co’s Leland Gershell issued a research note saying that investors can view the acceptance of the response “as a modest positive given that many question the future of Entereg in any indication".
Atriance approved in Europe
Further good news for GSK came with the announcement that Atriance (nelarabine) has received approval from the European Commission for the treatment of patients with difficult-to-treat forms of leukaemia and lymphoma.
Specifically, Atriance has been approved to treat patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens. There are only a few hundred patients diagnosed with relapsed/refractory T-ALL/T-LBL each year in Europe and they tend to have a worse prognosis than those with B-cell disease.
Andrew Witty, president for European pharmaceuticals, said that “full development for nelarabine began in the 1990s and it has taken over a decade of GSK development” and participation in collaborations with organisations such as the National Cancer Institute in the USA “to provide the data to bring this product to market in Europe.”