GlaxoSmithKline (GSK) has won a further reprieve for its blockbuster lung drug Advair (fluticasone propionate and salmeterol inhalation powder) after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug, Reuters reports.
The Jordan-based firm said it expected to submit a response to the FDA with new clinical data in 2019.
Hikma’s partner on the project, Vectura, said this meant a potential approval and launch of the generic inhaled medication could come in 2020 if all goes well, according to Reuters.
Shares in Hikma fell 1% in early trade, while Vectura lost 5%.
Hikma already faced a delay in U.S. approval for its Advair generic in 2017, as did rival generics company Mylan, and last month a third Advair copy from Novartis’s Sandoz division also got knocked back by the FDA.
Hikma had disputed the FDA’s demand that it conduct a fresh clinical endpoint study, but the agency upheld its original determination.
After Hikma and Mylan’s problems in 2017, most industry analysts expected the generic threat had been pushed back until mid-2018. The latest snags mean GSK may enjoy more Advair profits for longer, although Mylan still has a chance to win a U.S. green light for its version of generic Advair in 2018, the report said.
The timing of the arrival of generic Advair in the United States is critical to GSK’s near-term earnings outlook. The drug-maker expects its 2018 earnings, at constant exchange rates, to be flat to down 3% if generic Advair launches in the U.S market by mid-year. Without generics, earnings would be up 4% to 7%.
Source: Reuters; March 12, 2018.