Update on US NDA timelines for NVA237 and QVA149
Tokyo, Japan – 25 October 2011: Sosei Group Corporation (“Sosei”; TSE
Mothers Index: 4565), notes that Novartis has provided an update on NVA237
and QVA149 in its Q3 results today.
In the US, NVA237 will require additional clinical data to support submission and
will consequently be delayed. The changes to the US NVA237 program will
similarly impact approval timing for QVA149 in the US, where additional clinical
studies will be required. The QVA149 submission remains on track for 2012 in
EU and rest of world.
NVA237 (glycopyrronium bromide) has been submitted for approval in the EU
under the brand name Seebri® Breezhaler®, as a once-daily maintenance
treatment for chronic obstructive pulmonary disease (COPD). Results from the
Phase III GLOW3 study presented at the European Respiratory Society
Congress in September, showed that NVA237 50 mcg once-daily produced a
21% improvement in exercise endurance compared to placebo in
moderate-to-severe COPD patients. NVA237 was well tolerated, with a similar
incidence of adverse events for patients treated with NVA237 and with placebo.
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Enquiries:
Sosei Group Corporation
Tokyo Office London Office
Milica STOJKOVIC, Kathryn LYDON, PA to CEO &
Investor Relations Corporate Communication
+81-(0)3-5210-3399 +44-(0)20-7691-0983
mstojkovic@sosei.com KLydon@sosei.com