AstraZeneca ($AZN) snagged EU approval for its gout drug Zurampic, a few months after the med got an FDA green light. The regulatory blessing helps the U.K. drugmaker as it looks to new meds to fill the void for its top sellers Crestor and Nexium, which are facing increased generic competition.
The European Commission (EC) approved a 200-mg dose of Zurampic in combination with a xanthine oxidase inhibitor to treat hyperuricemia, or excess uric acid, in adult patients with gout. Regulators based their approval on three pivotal Phase III studies, which showed that the drug could lower serum uric acid levels to treat the condition.
"There has been limited therapy innovation in gout over the last 50 years," Sean Bohen, AstraZeneca's CMO and EVP of global medicines development, said in a statement. "With the approval of Zurampic, we are pleased to offer a new treatment option for many patients who are suffering from the effects of gout and who are not reaching the recommended serum uric acid treatment targets with the current standard of care."
AstraZeneca has big plans in store for Zurampic, which it picked up through its $1.3 billion deal for Ardea Biosciences in 2013. The company figures that the drug can rake in $500 million-plus in sales.
Some analysts peg this number even higher. Bernstein analyst Tim Anderson has projected 2020 sales for the drug of $582 million, and others see Zurampic reaching blockbuster status as more patients turn to gout meds.
Still, the drug doesn't come without its risks. In light of safety concerns raised by its advisory panel, the FDA saddled Zurampic with a black-box warning on potential renal failure. And the agency required AstraZeneca to run a postmarketing study to evaluate the med's renal and cardiovascular safety. European regulators are also requiring a postmarketing cardiovascular safety study for the drug as part of their approval.
AstraZeneca got another boost in the EU this week with expanded approval for its heart med Brilique, which helps prevent blood clots. Regulators signed off on a lower, 60-mg dose of the drug in patients who continue to take Brilique one year after having a heart attack. Before, the drug was only approved at a 90-mg dose to treat people for a 12-month period.
"A growing body of evidence continues to show that the risk of experiencing a subsequent cardiovascular event continues beyond the first year after a patient has a heart attack," Bohen said. "We are committed to finding new treatment solutions for these patients who remain at risk, and today's approval is an important step forward in meeting this need."
Additional approvals for Zurampic and Brilique help AstraZeneca at a critical moment, as it concentrates on new meds to deliver sales. "We are working as hard and as fast as we can to fill this gap created by the loss of Crestor and Nexium," CEO Pascal Soriot said last year after announcing Q3 results.
And 2016 will be "a pivotal year in our strategic journey," Soriot said, especially after Crestor falls off the patent cliff in the U.S. The company is counting on ovarian cancer drug Lynparza and lung cancer med Tagrisso to pitch in as it braces for the loss.
- read the Zurampic statement
- here's the Brilique release