The Eu­ro­pean Med­i­cines Agency on Fri­day said that Mer­ck’s an­tivi­ral mol­nupi­ravir can now be used to treat adults with Covid-19 who do not re­quire sup­ple­men­tal oxy­gen and who are at in­creased risk of de­vel­op­ing se­vere dis­ease.

The pill, known com­mer­cial­ly in Eu­rope as Lagevrio, has not yet been au­tho­rized in the US and has to be tak­en twice a day for 5 days. The EMA said it should be ad­min­is­tered as soon as pos­si­ble af­ter di­ag­no­sis of Covid, and with­in 5 days of the start of symp­toms. The quick au­tho­riza­tion is based on da­ta show­ing the drug re­duced the chance that a new­ly di­ag­nosed Covid-19 pa­tient would be hos­pi­tal­ized or die by 50%, ac­cord­ing to da­ta pre­sent­ed by the com­pa­ny in Oc­to­ber.

There are some safe­ty con­cerns too, as the EMA notes:

Lagevrio is not rec­om­mend­ed dur­ing preg­nan­cy and in women who can be­come preg­nant and are not us­ing ef­fec­tive con­tra­cep­tion. Women who can be­come preg­nant must use ef­fec­tive con­tra­cep­tion dur­ing treat­ment and for 4 days af­ter the last dose of Lagevrio. Breast­feed­ing should be in­ter­rupt­ed dur­ing treat­ment and for 4 days af­ter treat­ment. These rec­om­men­da­tions are giv­en as lab­o­ra­to­ry stud­ies in an­i­mals have shown that high dos­es of Lagevrio can im­pact the growth and de­vel­op­ment of the foe­tus.

Mean­while, the EMA is al­so re­view­ing Pfiz­er’s oral an­tivi­ral too, which showed an 89% re­duc­tion in risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death from any cause com­pared to place­bo. The FDA is cur­rent­ly re­view­ing EUA ap­pli­ca­tions for both drugs.

Dis­tri­b­u­tion of mAb treat­ments for Covid-19 in US see first uptick in 7 weeks

As the Delta vari­ant surged in cer­tain ar­eas of the US with low vac­ci­na­tion rates, the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse said it saw a 20-fold in­crease in or­ders for mon­o­clon­al an­ti­body ther­a­peu­tics (mAbs) to treat Covid-19.

In re­sponse to this in­crease in de­mand, AS­PR tran­si­tioned to a mAb dis­tri­b­u­tion sys­tem that’s co­or­di­nat­ed by states and ter­ri­to­ries in Sep­tem­ber. While some states like Michi­gan and Penn­syl­va­nia have seen in­creas­es in mAb sup­plies from GSK/Vir, Re­gen­eron and Eli Lil­ly’s prod­ucts, over­all as a coun­try, the num­ber of mAbs dis­trib­uted steadi­ly de­clined from al­most 200,000 dos­es dis­trib­uted in the week of Sept. 21, to on­ly about 100,000 dos­es dis­trib­uted na­tion­wide for the week of Nov. 8.

Now, per­haps in prepa­ra­tion for ris­ing num­bers of in­fec­tions as the win­ter months take hold, that num­ber of mAb dos­es dis­trib­uted has sky­rock­et­ed back up to about 175,000 dos­es dis­trib­uted na­tion­wide. Whether that’s just an­oth­er fluc­tu­a­tion in the week-to-week dis­tro sys­tem re­mains to be seen.

Over­all, the num­ber of dos­es dis­trib­uted by Re­gen­eron con­tin­ues to out­pace those shipped from GSK and Lil­ly, and an­oth­er com­peti­tor may hit the mar­ket next year.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.