The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 16-1 that the ben­e­fits of Pfiz­er’s Covid-19 pill Paxlovid out­weigh the risks in adults with mild-to-mod­er­ate ill­ness.

The vote fol­lowed hours of dis­cus­sion on top­ics rang­ing from ef­fi­ca­cy in peo­ple who have al­ready been vac­ci­nat­ed or in­fect­ed to drug-drug in­ter­ac­tions (DDIs). Pfiz­er sub­mit­ted a re­quest to con­vert its EUA to a full ap­proval back in June, but the FDA ex­tend­ed its re­view pe­ri­od by three months to con­sid­er ad­di­tion­al da­ta sub­mit­ted, the com­pa­ny an­nounced in De­cem­ber. The cur­rent PDU­FA ac­tion date for a de­ci­sion by the FDA is May 2023.

Just one com­mit­tee mem­ber vot­ed against the ques­tion: “Is the over­all ben­e­fit-risk as­sess­ment fa­vor­able for Paxlovid (nir­ma­trelvir and ri­ton­avir tablets) when used for the treat­ment of mild-to-mod­er­ate COVID-19 in adults who are at high risk for pro­gres­sion to se­vere COVID-19, in­clud­ing hos­pi­tal­iza­tion or death?”

While mem­bers who vot­ed yes agreed that ef­fi­ca­cy and safe­ty have been demon­strat­ed, they added that it’s im­por­tant to un­der­stand who is at high-risk and who will ben­e­fit from the drug. They al­so echoed the need to keep an eye on DDIs, as well as on­go­ing and fu­ture stud­ies by Pfiz­er on symp­to­matic re­bound and the drug’s im­pact on im­muno­sup­pressed, pe­di­atric and preg­nant pa­tients.

Pa­tient rep­re­sen­ta­tive Ter­ry Gille­spie, who vot­ed no, said she has one lung and has had Covid four or five times. Gille­spie said she was nev­er of­fered Paxlovid by med­ical pro­fes­sion­als and is “con­cerned about the doc­tors know­ing ac­tu­al­ly when to pre­scribe it to some­body, say, like me.”

In com­ments on the strength of ev­i­dence for use of Paxlovid in pa­tients who have al­ready been vac­ci­nat­ed or pre­vi­ous­ly in­fect­ed, com­mit­tee mem­bers said more da­ta are need­ed.

“I would just agree with those that said the ev­i­dence isn’t as com­pelling as in those that are un­vac­ci­nat­ed,” com­mit­tee mem­ber Paige Wa­ter­man said. “I don’t think we’re ever go­ing to have a ful­ly vac­ci­nat­ed pop­u­la­tion, what­ev­er ful­ly vac­ci­nat­ed means, al­though tak­en to­geth­er with pri­or in­fec­tion I guess would give us de­cent num­bers. I agree with the points made about in­di­vid­u­al­ize de­ci­sions. As we’re say­ing, physi­cians need to rec­og­nize in­di­ca­tions. Who meets this cri­te­ria?”

If grant­ed full ap­proval, Paxlovid’s EUA will re­main in place so that ado­les­cents 12 years and old­er can con­tin­ue to be treat­ed with the drug. In the US, more than 10 mil­lion treat­ment cours­es of Paxlovid have been pre­scribed to date, ac­cord­ing to Pfiz­er.

While the FDA does not need to fol­low an ad­comm’s rec­om­men­da­tions, it typ­i­cal­ly does. Pfiz­er has an on­go­ing tri­al for Paxlovid in chil­dren and plans to file a sup­ple­men­tal NDA for ap­proval in chil­dren.

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.