Pharmaceutical company GlaxoSmithKline (GSK) has received NDA (new drug application) approval from the US Food and Drug Administration for its oral chronic kidney disease drug Daprodustat.
The drug was developed using unique Nobel Prize-winning science that shows how cells adapt and sense the availability of oxygen. The FDA has indicated a response date no later than 1 February 2023.
The new drug application approval was supported by positive data from late-stage clinical trials which demonstrated the effectiveness and safety of Daprodustat against a spectrum of chronic kidney diseases.
The shares fell 1.5% to £17.47, after having gained around a quarter over the last six months and over 8% over the last three months.
The company is expected to spin off its consumer healthcare unit, named Haleon, sometime around the middle of 2022.
STEADY REGULATORY PROGRESS
Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia, a chronic kidney disease. Meanwhile, the EMA (European Medicines Agency) has validated a marketing authorisation application, currently under review, and additional filings are expected during 2022.
Chronic kidney disease is characterised by the progressive loss of kidney function and afflicts over 700 million people globally.
When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.
SALES POTENTIAL
Daprodustat offers patients a more convenient alternative treatment that requires less supervision from a doctor. GSK has estimated peak annual sales for the drug of between $675 million and $1.3 billion.
To put that into context, pharmaceutical consultants Research and Markets have forecast the global chronic kidney disease market will grow around 3.4% per year to reach $6.6 billion annually by the end of this decade.
