GSK and Innoviva bring forward US filing of NDA for COPD combo
UK pharma major GlaxoSmithKline (LSE: GSK) and its US partner Innoviva (Nasdaq: INVA) have brought forward the proposed date for their filing of a New Drug Application in the USA for the closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol, for chronic obstructive pulmonary disease (COPD).
They announced on Thursday that, following discussions with the US Food and Drug Administration (FDA), it now expected to make the regulatory submission by the end of this year, rather than in the first half of 2018 as was previously anticipated.
The NDA will comprise data now in hand from the once-daily closed triple combination therapy development program, as well as findings from other studies on the molecules alone and combined with others.
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