Shares in GlaxoSmithKline (LON:GSK have fallen deep into the red in today’s session as the company reported that an advisory committee of the US Food and Drug Administration (FDA) had voted against the approval of the group’s asthma drug Nucala for the treatment of patients with chronic obstructive pulmonary disease (COPD). The news comes hot on the heels of the pharmco’s interim update yesterday.
As of 14:25 BST, GSK’s share price had given up 2.24 percent to 1,507.80p. The stock is underperforming the broader UK market, with the benchmark FTSE 100 index currently standing 0.03 percent in the red at 7,656.03 points.
GSK reports Nucala setback
GSK announced in a statement today that the FDA’s Pulmonary Allergy Drugs Advisory Committee had voted against the approval of the group’s mepolizumab drug, marketed as Nucala, as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD guided by blood eosinophil counts. The committee concluded on the basis of data presented that the risk-benefit profile was not adequate to support approval.
Mepolizumab, which is already approved as an asthma treatment, is not currently approved for use in COPD anywhere in the world. Reuters noted in its coverage of the news that while the FDA is not obliged to follow the advice of its experts, it generally does.
Analysts on blue-chip pharmco
Deutsche Bank reaffirmed GSK as a ‘hold’ today without specifying a price target on the shares, while Credit Suisse, which is ‘neutral’ on the blue-chip drugmaker, boosted its valuation on the stock from 1,450p to 1,600p. According to MarketBeat, the FTSE 100 group currently has a consensus ‘hold’ rating and an average price target of 1,586.90p.