A few months ago, Mer­ck emerged as a clear leader among a group of drug­mak­ers rac­ing through the clin­ic with a new class of ther­a­pies for chron­ic cough. But it looks like the Ke­nil­worth, NJ-based phar­ma will now be tak­ing an­oth­er lap.

The FDA is de­lay­ing its de­ci­sion on Mer­ck’s gefapix­ant by at least a few months to “pro­vide time for a full re­view of the sub­mis­sion,” the com­pa­ny re­vealed in an SEC fil­ing. The agency, which orig­i­nal­ly set a PDU­FA date for Dec. 21, now ex­pects to make a de­ci­sion by March 21.

Gefapix­ant is one of a few P2X3 re­cep­tor an­tag­o­nists com­pet­ing in the re­frac­to­ry chron­ic cough set­ting, in­clud­ing can­di­dates from Bay­er and Sh­iono­gi. But af­ter Mer­ck’s chief ri­val Bel­lus flopped in a Phase II tri­al last sum­mer, it could be any­one’s game.

For gefapix­ant, the FDA is bas­ing its de­ci­sion on some mixed da­ta from two Phase III tri­als dubbed COUGH-1 and COUGH-2. Re­searchers linked the 45 mg dose to an 18.5% es­ti­mat­ed rel­a­tive risk re­duc­tion in 24-hour cough fre­quen­cy in COUGH-1, meet­ing the pri­ma­ry end­point (p=0.041). In COUGH-2, the same dose led to a 14.6% rel­a­tive risk re­duc­tion (p=0.031). The 15 mg dose, how­ev­er, failed in both tri­als.

Gefapix­ant missed a sec­ondary end­point of awake coughs per hour in COUGH-1, but the high­er dose reached sta­tis­ti­cal sig­nif­i­cance in COUGH-2. In­ves­ti­ga­tors al­so flagged high dropout rates due to ad­verse events, in­clud­ing taste-re­lat­ed side ef­fects, which were ex­pe­ri­enced by more than half of pa­tients giv­en the high­er dose in both tri­als, com­pared to un­der 10% of pa­tients in the place­bo arms.

Bel­lus’ pitch cen­ters on a more se­lec­tive ap­proach that avoids taste-al­ter­ing side ef­fects — but in a mid-stage study, all four dos­es of BLU-5937 fell short of the mark for place­bo-ad­just­ed re­duc­tions in cough­ing. In a Phase IIb study, the com­pa­ny’s en­rolling pa­tients with a base­line awake cough fre­quen­cy of ≥25 awake coughs per hour, where da­ta sug­gest the drug will have a bet­ter chance.

Bay­er’s eli­apix­ant met the pri­ma­ry end­point in a Phase IIb study ear­li­er this month, sig­nif­i­cant­ly im­prov­ing 24-hour cough fre­quen­cy (though the com­pa­ny has yet to re­lease hard da­ta). Sh­iono­gi’s sivopix­ant is in an on­go­ing Phase II study, ac­cord­ing to its web­site.

Mer­ck’s Roy Baynes has big plans for gefapix­ant as a po­ten­tial “pipeline in a prod­uct.” Af­ter buy­ing Af­fer­ent Phar­ma and its P2X3 plat­form for $500 mil­lion up­front in 2016, the com­pa­ny plot­ted a whole range of pro­grams in en­dome­tri­al-re­lat­ed pain, sleep ap­nea and oth­er sen­so­ry re­lat­ed func­tions.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.