IQWiG assesses Inlyta, aclidinium bromide

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said Inlyta axitinib from Pfizer Inc. (NYSE:PFE) provides a "significant additional benefit" over Nexavar sorafenib to treat advanced renal cell carcinoma (RCC) in patients who have failed treatment with a cytokine. The institute said in the Phase III AXIS 1032 trial there were no significant differences between the two drugs on overall mortality but patients receiving Inlyta had fewer side effects than those on Nexavar. IQWiG said Inlyta did not show an additional benefit over Afinitor everolimus to treat advanced RCC in patients who failed prior therapy with Pfizer's Sutent sunitinib because the pharma did not include "suitable" data in its dossier. Inlyta is approved to treat RCC in patients who fail treatment with Sutent or a cytokine. Germany's Federal Joint Committee (G-BA) requested Nexavar as a comparator in patients who failed treatment with a cytokine, and Afinitor as a comparator in patients who failed treatment with Sutent. Novartis AG (NYSE:NVS; SIX:NOVN) markets Afinitor.

Separately, IQWiG said Bretaris/ Eklira Genuair aclidinium bromide from Almirall S.A. (Madrid:ALM) has "no additional benefit" over Spiriva HandiHaler tiotropium for chronic obstructive pulmonary disease (COPD). The institute said data submitted by Almirall directly comparing the two products were from studies that were only two to six weeks in duration; IQWiG said it would need data from studies at least six months long. The institute said data included by Almirall from studies indirectly comparing the products for at least six months were "not useable" because data including patient numbers and confidence intervals were "not consistent with the original data." Almirall could not be reached for comment. Boehringer Ingelheim GmbH (Ingelheim, Germany) markets Spiriva. ...