Soon af­ter San Fran­cis­co-based Genen­tech won an EUA for tocilizum­ab as a treat­ment for hos­pi­tal­ized Covid pa­tients last sum­mer, the com­pa­ny an­nounced a short­age of the drug while point­ing to the emer­gence of the Delta vari­ant and the slow­ing of vac­ci­na­tion rates across the US.

“This new wave of the pan­dem­ic has led to Genen­tech ex­pe­ri­enc­ing an un­prece­dent­ed de­mand for Actem­ra IV– well-over 400% of pre-COVID lev­els over the last two weeks alone and it con­tin­ues to in­crease,” the com­pa­ny said in Au­gust.

More re­cent­ly, the short­age is caus­ing is­sues for oth­ers who might need tocilizum­ab fol­low­ing the in­fu­sion of CAR-T cell im­munother­a­pies as can­cer treat­ments, due to the po­ten­tial for se­vere or even life-threat­en­ing cy­tokine re­lease syn­drome.

All CAR-Ts are sub­ject to risk eval­u­a­tion and mit­i­ga­tion strate­gies (REMS) OKed by the FDA, which in this case re­quire that pri­or to CAR-T in­fu­sions, a min­i­mum of two dos­es of tocilizum­ab are avail­able on-site for each pa­tient and are ready for im­me­di­ate ad­min­is­tra­tion (with­in 2 hours) due to the po­ten­tial for CRS.

The world­wide short­age of tocilizum­ab means the FDA has to get flex­i­ble with its re­quire­ment that two dos­es be on site, and the agency is­sued new guid­ance on Fri­day ex­plain­ing how.

For CAR T cell im­munother­a­pies sub­ject to these REMS, the FDA says it does not in­tend to ob­ject if health care providers pre­scribe, dis­pense, or ad­min­is­ter these bi­o­log­ics when two dos­es of tocilizum­ab are not avail­able, pro­vid­ed that all of the fol­low­ing cir­cum­stances are ac­count­ed for:

• Be­fore in­fu­sion of the CAR-T im­munother­a­py to a pa­tient, one dose of tocilizum­ab is avail­able on-site for each pa­tient for im­me­di­ate ad­min­is­tra­tion (with­in 2 hours), and there is ac­cess to an ad­di­tion­al dose of tocilizum­ab with­in 8 hours af­ter each pre­vi­ous dose, if need­ed.
• Health care providers use their best med­ical judg­ment in weigh­ing the ben­e­fits and risks of treat­ment with the CAR T cells in the con­text of the short­age. “There are lim­it­ed da­ta to sup­port the use of al­ter­na­tive agents di­rect­ed against in­ter­leukin (IL)-6 or oth­er cy­tokines for CRS man­age­ment in gen­er­al, and in par­tic­u­lar, as first-line ther­a­py,” FDA notes.
• Health care providers com­mu­ni­cate with their pa­tients re­gard­ing their de­ci­sion-mak­ing, in­clud­ing the risks and ben­e­fits of treat­ment with CAR T cell im­munother­a­py in the con­text of the tocilizum­ab short­age, and the po­ten­tial chal­lenges in the treat­ment of CRS and po­ten­tial use of al­ter­na­tive CRS man­age­ment ap­proach­es.

Un­der the REMS, cer­ti­fied hos­pi­tals and their as­so­ci­at­ed clin­ics al­so should main­tain ad­e­quate records of pa­tient-lev­el da­ta re­gard­ing the use of CAR T cell im­munother­a­pies and must doc­u­ment and re­port any se­ri­ous ad­verse events sug­ges­tive of CRS or neu­ro­log­i­cal tox­i­c­i­ty, the FDA says.

Genen­tech al­so must main­tain records of cer­ti­fied hos­pi­tals and their as­so­ci­at­ed clin­ics that were not able to com­ply with REMS re­quire­ments and in­stead pro­vide CAR T cell im­munother­a­py in a man­ner con­sis­tent with this pol­i­cy due to the tocilizum­ab short­age.

“Al­though all REMS re­quire­ments re­main in ef­fect dur­ing this time, FDA does not in­tend to take en­force­ment ac­tion against spon­sors or oth­ers with re­spect to the REMS re­quire­ments re­lat­ing to the ac­cess to tocilizum­ab” dur­ing this short­age, the agency adds.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.