Drugs

BI Wants COPD Triple-Combination Restrictions

Boehringer Ingelheim says FDA should ensure that any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease is not approved as safe and effective unless it meets Combination Rule requirements. In a petition, the company asks that FDA not approve any such NDA unless:

it is supported by pivotal Phase 3 clinical trials that use active comparators containing the same active ingredients as those contained in the proposed triple-combination therapy and not simply active ingredients in the same therapeutic categories; and
it is supported by pivotal Phase 3 clinical trials that use a factorial design adequate to demonstrate that each active ingredient in the proposed triple-combination makes a contribution to the claimed effects.

The petition also asks that a meeting of the Pulmonary-Allergy Drugs Advisory Committee be convened before the agency approves any NDA for a fixed-dose, triple-combination product for treating patients with COPD that does not meet the Combination Rule requirements described in the petition.

According to Boehringer Ingelheim, GlaxoSmithKline announced 11/21/16 that it had submitted an NDA for a once-daily, closed triple-combination therapy containing fluticasone furoate, umeclidinium, and vilanterol for treating patients with COPD. It says that if approved, it would be the first such inhaled combination available in the U.S. The petition says that the primary support for the application appears to be the FULFIL study that does not allow a comparison of the triple-combination to any of the active ingredients in the combination or any combinations of those active ingredients. The petition says that Glaxo reportedly is conducting a second Phase 3 trial, IMPACT, that will compare the triple-combination ingredients against two approved once-daily products containing combinations of the active ingredients in the triple-combination.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome