FDA sends Hikma back to the clinic with generic Advair

Three Advair challengers have now faced rejections from the FDA.

GlaxoSmithKline just keeps racking up the victories in the generic Advair department.

Partners Hikma and Vectura have officially wrapped up their dispute with the FDA, and the result isn't good for the companies. The agency is sending the pair back to the drawing board with a request for an additional clinical endpoint study.

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The roadblock will delay the duo’s Advair copycat until 2020, Vectura said, although as it pointed out, it could have been worse. After receiving a “no” from regulators and striking up a dispute with the FDA, Hikma started planning the study “in anticipation of this as one of the potential outcomes.”

Now, the Jordanian drugmaker expects to start enrolling patients “in the coming weeks” and plans to submit a response complete with new data “as early as possible in 2019,” Vectura said.

Meanwhile, the setback marks another break for GlaxoSmithKline, which has watched the FDA turn away three separate challengers to its respiratory behemoth. Mylan was first in line for a rejection last March, with Hikma and Vectura’s following in May.

Those denials set Novartis’ Sandoz up for a come-from-behind victory, but when the agency last month asked the generics giant for more data, Sandoz told investors it was “highly unlikely” its version would launch this year.

Glaxo has long been prepping for the arrival of an Advair knockoff, building the possibility into its 2017 guidance. Last month, the company told investors that if copies hit in the middle of this year, they’d eat up half the drug’s U.S. sales.

Mar 13, 2018

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