Trending News Today: FDA Requests More Data to Support Nucala Approval for COPD
Top news of the day from across the health care landscape.
GlaxoSmithKline (GSK) announced that the FDA sent a complete response letter (CRL) regarding its application for mepolizumab (Nucala) as an add-on treatment to inhaled corticosteroid-based maintenance treatment for chronic obstructive pulmonary disease (COPD), Reuters reported. According to the article, the CRL stated that more clinical data are required to support an approval. The agency previously approved the drug for the treatment of severe asthma, the article reported.
An investigational flu drug has shown promising results in clinical trials but some data raise concerns, STAT reported. According to the article, the drug baloxavir marboxil reduced the duration that individuals were sick with flu symptoms by little over a day and drastically reduced the amount of viruses patients had in their upper respiratory tracts. However, the drug did not make individuals feel better faster than oseltamivir (Tamiflu) and the studies also showed that viral resistance could develop rapidly against the drug, the article reported.
A new study found that more than 1 in 9 individuals worldwide who were eligible for HIV pre-exposure prophylaxis (PrEP) are taking the drug, Reuters reported. According to the article, the researchers examined data from 72 studies published from 2006 to 2018. In the US, nearly 1 in 6 participants and nearly 1 in 4 men who have sex with men who were eligible for the pill were using it by 2016, the article reported.