The global COVID-19 pandemic has put efforts to defeat tuberculosis (TB) back 12 years, the Stop TB Partnership reported March 18. Nine countries with the most TB cases, representing 60% of the global TB burden, experienced drastic declines in TB diagnosis and treatment last year, with those declines ranging from 16% to 41%. Meanwhile, “data emerging from India and South Africa shows that people coinfected with TB and COVID-19 have three times higher mortality than people infected with TB alone,” the group said. Projections last year showed that a three-month pandemic lockdown, followed by a protracted 10-month restoration, could result in an additional 6.3 million cases of TB worldwide between 2020 and 2025 and an additional 1.4 million deaths. So far, the impact has outpaced the projections. Noting how quickly COVID-19 vaccines were developed, Thokozile Phiri Nkhoma, a Stop TB Partnership board member, pointed out that “although TB has been around since the time of the pharaohs, the only approved vaccine is 100 years old and doesn’t fully work, especially in adults.” In addition, first-line TB treatment is several decades old, and drug resistance is on the rise.
CDER makes COVID-19 EUA data easier to find
The FDA’s Center for Drug Evaluation and Research (CDER) launched a website to disclose information from its scientific review documents supporting emergency use authorizations (EUAs) for COVID-19 drugs and biologics. Citing its longstanding practice of posting scientific reviews following the approval of new drugs and biologics, CDER said it was compiling the COVID-19 EUA review documents in one location to make them easier to find. Currently, the website includes documents for four EUAs – Eli Lilly and Co.’s bamlanivimab and bamlanivimab/etesevimab, Lilly’s Olumiant (baricitinib) in combination with Gilead Sciences Inc.’s Veklury (remdesivir) and Regeneron Inc.’s REGEN-COV (casirivimab and imdevimab).
NICE recommends use of CLL drug
The U.K.’s National Institute for Health and Care Excellence (NICE) is recommending Astrazeneca plc’s Calquence (acalabrutinib), taken twice daily, as a monotherapy option for adults with chronic lymphocytic leukemia (CLL). In making the recommendation, NICE said the evidence shows the drug is clinically effective in CLL and that it improves the quality of life for people living with the condition. The recommendation follows an undisclosed discount Astrazeneca offered the government. Without the discount, a 30-day pack of the drug costs £5,059, or US$7,047, according to NICE.