Articles related to FDA

In 2019, the FDA warned that gabapentin might cause serious breathing difficulties when used with drugs that depress the central nervous system. The warning may have not been heeded, as overdose deaths in which gabapentin was detected doubled from 449 in the first quarter of 2019 to 959 in the second quarter of 2020.

Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), is indicated for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Based on the results of a clinical trial evaluating the long-term effects of the drug, the FDA recommends that health care providers evaluate the risks and benefits of continuing Copiktra vs. prescribing an alternative therapy.

RhoVac AB’s RV001 (onilcamotide) was granted Fast Track designation by FDA based on positive performance in its phase I/II trial. Unfortunately, in the follow-on Phase IIb BRaVac trial, the drug failed to demonstrate superiority over the placebo.

In the study,155 FDA-approved drugs with 136 potentially targetable genes were identified.One-hundred forty-six (94%) of the drugs showed no or low genetically predicted drug response. Although ATC-carrying BRAF mutations can benefit from BRAF inhibitors and this effect might be enhanced by a combined strategy including PIK3CA inhibitors in some of the patients, alterations in BRAFWT ATC are not directly targeted by currently FDA-approved options.

Hutchmed’s submission was based primarily on two phase 3 trials conducted in China. Even though a bridging study conducted in the US that suggested safety and efficacy similar to that observed in the Chinese study population, FDA responded that a multiregional clinical trial “more representative of the US patient population and in accordance with US medical practice will be required” for resubmission.

Mounjaro (tirzepatide) is a first-in-class, once-weekly, dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule. It enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner. The FDA approval of Mounjaro as an adjunct therapy to diet and exercise for adults with type 2 diabetes was based on clinical trials where treatment with Mounjaro resulted in statistically significant reduction in both A1c and weight vs. semaglutide, insulin degludec, and insulin glargine.