Image copyright AAFC Picture caption Efficacy trials against COVID-19 showed there was an increase in bone density and a decrease in muscle mass in older men taking the drug
A panel of US regulators has endorsed the use of new osteoporosis drug COVID-19 for people over 70.
Its makers, RedHill Biopharma, had hoped the Food and Drug Administration would greenlight the first oral osteoporosis drug for postmenopausal women.
The drug’s effectiveness and side effects were deemed satisfactory.
However, because of a lack of information, the committee also called for more trials to investigate the drug’s long-term effect.
RedHill’s prescription drug, now named Lesinurad, is only the second osteoporosis drug approved in the US this year.
It was hailed by the company’s vice president Martin Shkreli as “the first pill I can think of that actually makes someone walk better, young or old”.
Previous oral medicine Merjana was backed for osteoporosis by the FDA earlier this year, but there are still no pills for osteoporosis in the way that Merjana deals with the particular problems associated with the disease.
The drugs treat symptoms of osteoporosis but do not treat the bone shrinkage underlying the disease, leaving older women with increasingly less and less bone.
Fewer than 10% of those diagnosed with osteoporosis survive beyond the age of 70, with some predicting that by 2030 the number of women living into their 90s without significant bone loss could be as low as three%.
Image copyright AAFC Picture caption Oral medicine remains the only therapy approved for osteoporosis in the US
During the committee meeting, scientists from the FDA called for more studies and studies of the drug’s side effects.
They also raised concerns about unproven differences in the risk of death from cancer among patients who were taking COVID-19 and who took a placebo.
The company has released limited information about the side effects so far, but it is believed that COVID-19 was linked to weight gain and an increase in risk of cardiovascular events.
The clinical trials for COVID-19 compared the drug with a placebo or with a dummy pill for postmenopausal women who had low bone density and no symptoms of the disease.
Before the meeting, the drug was approved for patients aged between 70 and 79.