While Mer­ck’s Covid-19 an­tivi­ral mol­nupi­ravir has been giv­en EUA in the US, it has still been pend­ing au­tho­riza­tion in Eu­rope. And ac­cord­ing to a new re­port from the Fi­nan­cial Times, the EMA might not rec­om­mend grant­i­ng con­di­tion­al mar­ket­ing au­tho­riza­tion — po­ten­tial­ly shut­ting Mer­ck’s an­tivi­ral out of one of the world’s largest drug mar­kets.

Peo­ple fa­mil­iar with the ap­proval process told the news or­ga­ni­za­tion that the EMA is un­like­ly to grant con­di­tion­al mar­ket­ing au­tho­riza­tion to Mer­ck’s Covid-19 an­tivi­ral as it wres­tles with “prob­lem­at­ic” da­ta.

It is “pos­si­ble” that the oral Covid drug mol­nupi­ravir will not re­ceive ap­proval at all, one of the peo­ple said.

Mer­ck’s an­tivi­ral made head­lines last year af­ter a tri­al sug­gest­ed that the an­tivi­ral drug was 50% ef­fec­tive against death and hos­pi­tal­iza­tion from Covid-19. How­ev­er, fur­ther study showed ef­fi­ca­cy to be low­er than that — clos­er to 30%. While the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee nar­row­ly vot­ed 13-10 back in De­cem­ber in fa­vor of the pill, cit­ing its ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms, a sum­ma­ry of the meet­ing shows that the com­mit­tee mem­bers who vot­ed “No” against the pill cit­ed the fol­low­ing rea­sons as to why: 1) a high num­ber-need­ed-to-treat com­pared with place­bo, 2) un­clear ef­fi­ca­cy against the Delta vari­ant, 3) po­ten­tial to dri­ve vi­ral mu­ta­tions, and 4) mu­ta­genic­i­ty risks.

The EMA gave the an­tivi­ral a pre­lim­i­nary nod last year af­ter re­view­ing ini­tial da­ta, al­low­ing EU mem­ber states to pre­scribe the drug be­fore mar­ket­ing au­tho­riza­tion was giv­en — some­thing that Mer­ck not­ed in a state­ment to End­points News.

“We be­lieve a range of med­i­cines and vac­cines are need­ed to make an im­pact on the pan­dem­ic and that it’s im­por­tant in med­i­cine to have a se­lec­tion of treat­ments avail­able for var­i­ous pa­tient groups,” Mer­ck said to End­points. “We are very con­fi­dent in the clin­i­cal pro­file of mol­nupi­ravir and are mov­ing with rig­or and ur­gency to bring this med­i­cine for­ward to pa­tients around the world.” 

Re­gard­ing the EMA: A Mer­ck spokesper­son said, “We are in ac­tive dis­cus­sions with reg­u­la­tors with aim of bring­ing mol­nupi­ravir to pa­tients in Eu­rope as quick­ly as pos­si­ble.”

And while the FDA re­strict­ed mol­nupi­ravir’s use in pa­tients un­der the age of 18 and pre­vent­ed use for more than 5 con­sec­u­tive days, French reg­u­la­tors de­clined to give mol­nupi­ravir the OK amid ef­fi­ca­cy con­cerns and the po­ten­tial im­pact of the Omi­cron vari­ant. The coun­try lat­er can­celed its or­der.

Mer­ck said on an earn­ings call late last year that it ex­pect­ed $5 bil­lion to $6 bil­lion in sales for the drug in 2022.

A per­son fa­mil­iar with the EMA ap­proval process told the Times that the drug had been “a bit of a dis­ap­point­ment” and that 30% ef­fi­ca­cy “start­ed to be on the lim­its of [what is con­sid­ered] ben­e­fit.” Some US phar­ma­cies have been re­port­ing that they have been run­ning out of space to store the pill — be­cause so few peo­ple are us­ing it.

Rather, peo­ple are be­ing pre­scribed both Pfiz­er’s pill Paxlovid and GSK/Vir’s mon­o­clon­al an­ti­body sotro­vimab for use ahead of mol­nupi­ravir — mak­ing the an­tivi­ral es­sen­tial­ly a third-line treat­ment.

Mer­ck’s share price has re­mained al­most ex­act­ly the same, with $MRK clos­ing at $77.84 yes­ter­day and open­ing this morn­ing at $77.17.

Ac­cord­ing to Eu­ro­pean of­fi­cials, health­care sys­tems in Eu­rope are al­so fa­vor­ing Paxlovid, which has re­port­ed 89% ef­fi­ca­cy in re­duc­ing death and hos­pi­tal­iza­tion.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.