February 27, 2024

The need-to-know this morning

Viking Therapeutics reported results from a mid-stage study of its obesity drug, called VK2735, showing average weight loss of 13%, adjusted for placebo, after 13 weeks. Gastrointestinal side effects were mild to moderate and discontinuations were equivalent across the placebo and VK2735 arms of the study. Viking's stock price doubled in pre-market trading.

antibiotics

GSK pill works in uncomplicated gonorrhea

Gepotidacin, an experimental oral antibiotic made by GSK, successfully cleared gonorrhea in patients — performing just as well as a combination of cetriaxone and azithromycin, the standard treatment. Gonorrhea is on the rise, and growing increasingly resistant to antibiotics; it is considered by the WHO as a priority pathogen.

GSK is also testing gepotidacin in uncomplicated urinary tract infections; work demonstrating its efficacy was published earlier this month in The Lancet. If the drug is approved, it would be the first in a new class of oral antibiotics for these infections in over two decades.

Gepotidacin was developed largely with funding from HHS, BARDA, and the Administration for Strategic Preparedness and Response. It was discovered by GSK scientists, and works by inhibiting bacterial DNA replication.

washington

Congress drops PBM reform from upcoming legislation

Congress will no longer include PBM reform in an upcoming federal funding bill, STAT's Rachel Cohrs and John Wilkerson report.

These pharmacy middlemen have attracted plenty of bipartisan interest, however, and lawmakers could still continue to negotiate the issue in upcoming legislation later this year.

The move to drop PBM reform for now is a bit of a surprise, given how much work both the House and Senate have been doing on the issue in recent months. For instance, the Senate Finance Committee assembled a package that would require that PBMs in Medicare charge flat service fees that aren't based on drug list prices. It would also require more discloser, tie some patient cost-sharing to net prices, and ban PBMs from charging Medicare more than they pay for drugs.

regulatory

Abortion debate over FDA's approval of mifepristone

The FDA approved the drug mifepristone in 2000 to aid abortion through seven weeks of gestation after an especially lengthy deliberation process. An anti-abortion advocacy called the Alliance of Hippocratic Medicine is arguing that the agency's rigor at the time — and the safeguards put in pace — are evidence that the pill is dangerous. The group has filed a lawsuit calling the drug's approval process into question.

But the safety measures put in place around mifepristone were meant to proactively brace against the political controversy around the pill, as opposed to potentially mitigating the physical risk of the drug, those involved with the approval told STAT.

"The FDA wanted everything to be super cautious, politically and scientifically, everything had to be in a formal study," said Beverly Winikoff, former director of reproductive health at Population Council, an NGO. "It's probably one of the most studied pills to ever reach the market."