With international scrutiny focusing on a narrowing set of drugs currently in tests to treat the symptoms of the novel coronavirus, drugmakers are already facing shortages that could threaten global supply. To counter that demand—and quash accusations of profiteering—Abbvie has reportedly taken a drastic step to open its COVID-19 candidate to competition.
AbbVie will not enforce global patent rights on all formulations of HIV med Kaletra (Aluvia) as the drug is being evaluated to treat severe COVID-19 in several clinical trials, the Financial Times reported.
A spokesperson for AbbVie could not be reached by press time.
The move would free countries to purchase Kaletra generics in the event of a shortage or if the drug is found to be effective in treating COVID-19 patients, according to the Times. AbbVie would be the first drugmaker to take that drastic move as at least one other drug cycling through coronavirus trials faces emergency access shortages.
Gilead Sciences temporarily stopped granting patients emergency access to remdesivir under compassionate use due to an “exponential increase” in requests over the last few days, the company said Sunday. Exceptions will be made for pregnant women and children under 18 with severe COVID-19, the disease caused by the novel coronavirus.
The spike of COVID-19 cases in Europe and the U.S. “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic,” it said.
As the company works to process previously approved requests, it’s devising expanded access programs for widespread treatment use, pivoting away from the current individual patient pathway.
Even with a suite of clinical trials ongoing, at least one small-scale study has argued Kaletra is not effective in treating COVID-19.
Data from a Chinese study showed Kaletra, a combination of antiviral drugs lopinavir and ritonavir, failed across the board in a 199-patient clinical trial. It didn’t top standard of care at improving clinical symptoms, extending life span or cutting viral shedding in patients hospitalized with severe COVID-19, results from a study published Wednesday in The New England Journal of Medicine showed.
Physicians at China’s Jin Yin-tan Hospital in the city of Wuhan—which was until recently the epicenter of the outbreak—concluded that Kaletra doesn’t offer additional benefits over standard care in COVID-19. However, Evercore ISI analyst Umer Raffat argued in a note to investors last week the drug shouldn't yet be written off, as it seems to have fared better among patients who started treatment sooner.
According to the study, the death rate in Kaletra patients was 15% at day 28 of therapy versus 27.1% among placebo patients, provided therapy started within 12 days of symptoms appearing, Raffat noted.
“Honestly, I want to see a further sub-cut of this data … perhaps for patients that initiated [Kaletra] less than eight days from symptom onset,” Raffat wrote.