GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults. The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not […]
Innoviva-GSK project Trelegy Ellipta meets main endpoint in asthma pivotal trial
A combination drug-device therapy developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not […]
Innoviva posts Street-beating Q4, FY17 earnings
Shares in Innoviva (NSDQ:INVA) rose today after the company topped expectations on Wall Street with its fourth quarter and full-year financial results. The Brisbane, Calif.-based company posted profits of $58.4 million, or 55¢ per share, on sales of $69.5 million for the 3 months ended Dec. 31, for bottom-line growth of 129% on sales growth of […]
EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta. If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist. […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Trelegy Ellipta, […]
Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting […]
FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler
The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today. The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules […]
GSK’s triple-med COPD inhaler wins recommendation for approval in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency panel recommended marketing authorization for the Trelegy Ellipta triple-combination inhaler for adults with COPD. The device uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. It’s also […]
Innoviva proposes $175m private placement
Innoviva (NSDQ:INVA) said today that it plans to offer $175 million in a private placement to certain qualified institutional buyers. The Brisbane, Calif.-based company said it expects to give initial buyers a 30-day option to buy up to an additional $17.5 million in notes. The terms of the convertible senior notes, which are due 2025, are […]
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