Due to the pres­ence of vari­ants, the US said Fri­day that it’s paus­ing ship­ments of Eli Lil­ly’s mon­o­clon­al an­ti­body com­bo for the treat­ment of Covid-19 on a na­tion­al ba­sis un­til fur­ther no­tice.

The pause, which could amount to the loss of about $375 mil­lion in sales ac­cord­ing to one biotech an­a­lyst, is an­oth­er blow to Lil­ly’s ef­forts to treat Covid-19 out­side of the hos­pi­tal, as the com­pa­ny pre­vi­ous­ly had its EUA for bam­lanivimab re­voked.

“The CDC iden­ti­fied that the com­bined fre­quen­cies of the SARS-CoV-2 P.1/Gam­ma vari­ant (first iden­ti­fied in Brazil) and the B.1.351/Be­ta vari­ant (first iden­ti­fied in South Africa) through­out the Unit­ed States now ex­ceed 11% and are trend­ing up­ward,” John Redd, CMO of the Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse, said in a let­ter ob­tained by End­points News.

“Re­sults from in vit­ro as­says that are used to as­sess the sus­cep­ti­bil­i­ty of vi­ral vari­ants to par­tic­u­lar mon­o­clon­al an­ti­bod­ies sug­gest that bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er are not ac­tive against ei­ther the P.1 or B.1.351 vari­ants,” Redd wrote.

Pre­vi­ous­ly, dis­tri­b­u­tion of the com­bo of bam­lanivimab and ete­se­vimab was halt­ed in 9 states, in­clud­ing Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon, Illi­nois, Mass­a­chu­setts, Rhode Is­land and Wash­ing­ton, as the com­bined fre­quen­cy of the Covid-19 vari­ants first iden­ti­fied in Brazil and South Africa ex­ceed­ed 10% then.

Lil­ly said in an emailed state­ment, “Bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er do not re­tain neu­tral­iza­tion ef­fects against the Gam­ma or Be­ta vari­ant. The U.S. Food and Drug Ad­min­is­tra­tion (FDA) rec­om­mends that health care providers in the U.S. use al­ter­na­tive au­tho­rized mon­o­clon­al an­ti­body ther­a­pies un­til fur­ther no­tice. As we have seen over the last sev­er­al months, preva­lence of vari­ants varies by state, re­gion and even coun­try and can change rapid­ly. Lil­ly con­tin­u­al­ly mon­i­tors the glob­al COVID-19 en­vi­ron­ment, as­sess­ing the neu­tral­iza­tion of our an­ti­body ther­a­pies against a wide ar­ray of ex­ist­ing and emerg­ing mu­ta­tions and vari­ants as well as the avail­able ther­a­pies.”

States will still have the op­tion of us­ing two mon­o­clon­al an­ti­bod­ies de­vel­oped by Re­gen­eron and Vir/GSK as the vari­ants do not evade ei­ther of those treat­ments as well as they did with the Lil­ly treat­ments.

Bern­stein biotech an­a­lyst Ron­ny Gal said in a note to in­vestors late last month that the mar­ket will now like­ly shift in Re­gen­eron’s fa­vor.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Lil­ly.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”