pharmatimesMay 05, 2020
Tag: GSK , Zejula , PARP inhibitor
GlaxoSmithKline has reported 19% growth in group sales to £9.1 billion for the first quarter.
The drug giant's pharmaceuticals division pulled in revenues of £4.4 billion, up 6% on a year ago (6% at constant exchange rates [CER]), while those from consumer healthcare rocketed 44% to £2.9 billion (46% CER) and vaccines grew 19% (19% actual and CER) to £1.9 billion.
Of particular note, total respiratory sales hit £871 million, up 38%, driven by Trelegy (fluticasone furoate/umeclidinium/vilanterol), which pulled in £193 million, rising 100%, and Nucala (mepolizumab), which came in at £210 million, marking growth of 38%.
The group reported total EPS of 31.5p, up 87% (89% CER) compared to the first quarter of last year, reflecting “good operating performance” and an increase in the value of shares in Hindustan Unilever relating to the disposal of Horlicks in India, according to GSK.
“Our business performed strongly in the quarter with growth in sales and earnings reflecting good underlying performance and increased demand, including stock-building, for many of our products,” said chief executive Emma Walmsley.
“Looking ahead, we clearly face a period of considerable uncertainty, but we remain confident in the resilience and sustainability of GSK’s business and our ability to deliver on our long-term priorities of Innovation, Performance and Trust.”
Zejula approval
The company also announced that US regulators have expanded the approved uses for Zejula (niraparib) to include first-line maintenance treatment for certain women with ovarian cancer.
Specifically, the decision allows for the drug's use as monotherapy maintenance treatment for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting, it said.
“Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress,” noted Hal Barron, GSK's chief scientific officer and president of R&D.
Zejula is the only once-daily PARP inhibitor approved in the US as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings, the firm noted.
The new indication is supported by data from the Phase III PRIMA study, which showed that Zejula significantly improved progression-free survival, regardless of biomarker status.
In the homologous recombination deficient (HRd population), Zejula resulted in a 57% reduction in the risk of disease progression or death versus placebo, and a 38% reduction in the overall population.
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