When Glax­o­SmithK­line earned its first ap­provals back in 2011 for Benlysta, it promised reg­u­la­tors it would keep the ball rolling in its pur­suit of lu­pus nephri­tis, a se­vere form of the au­toim­mune dis­ease that can cause re­nal fail­ure. Now, near­ly a decade af­ter the bi­o­log­ic first hit the mar­ket, GSK has made good on that promise.

The FDA on Thurs­day ap­proved in­tra­venous and sub­cu­ta­neous Benlysta to treat LN, mak­ing it the first ther­a­py ever ap­proved for that in­di­ca­tion.

The agency based its re­view on re­sults from the Phase III Bliss-LN study, which showed 43% of lu­pus nephri­tis pa­tients in the Benlysta plus stan­dard-of-care arm achieved pri­ma­ry ef­fi­ca­cy re­nal re­sponse — a mea­sure of kid­ney func­tion — com­pared with 32% of pa­tients in the place­bo group. Pa­tients on Benlysta al­so post­ed sig­nif­i­cant­ly high­er re­sponse in sec­ondary end­points, in­clud­ing time to death or a kid­ney-re­lat­ed com­pli­ca­tion.

Lu­pus nephri­tis is a se­vere form of sys­temic lu­pus ery­the­mato­sus that can cause late-stage re­nal fail­ure and re­quire dial­y­sis or kid­ney re­place­ment in the worst cas­es. Hav­ing a ther­a­py on the mar­ket that can cut in­to the de­mand for those sur­gi­cal pro­ce­dures is a big win for the 60% of 328,000 se­vere US lu­pus pa­tients suf­fer­ing from lu­pus nephri­tis each year, GSK said.

“In the four decades I have been car­ing for peo­ple with lu­pus, we have not been able to achieve re­mis­sion in more than just one-third of pa­tients with lu­pus nephri­tis and, de­spite all of our ef­forts, 10% to 30% of pa­tients with lu­pus kid­ney dis­ease still progress to end-stage kid­ney dis­ease,” said Richard Fu­rie, chief of the di­vi­sion of rheuma­tol­ogy and pro­fes­sor at the Fe­in­stein In­sti­tutes for Med­ical Re­search at North­well Health and lead in­ves­ti­ga­tor of the Bliss study, in a re­lease. “There­fore, it is grat­i­fy­ing to see the re­wards of decades of re­search.”

Ex­pect­ing an uptick in de­mand for Benlysta and look­ing to fi­nal­ly crack in­to block­buster ter­ri­to­ry, GSK has been quick­ly ex­pand­ing its man­u­fac­tur­ing ca­pac­i­ty to dri­ve sup­ply world­wide.

In Oc­to­ber 2019, GSK un­veiled plans to in­fuse $139 mil­lion plant at its Rockville, MD site to add ca­pac­i­ty for Benlysta. The drug­mak­er chose to retro­fit an ex­ist­ing build­ing at the Mary­land site, where it al­ready had ex­per­tise in pro­duc­ing the in­ject­ed or in­fused drug. The in­vest­ment was used to pay for the de­mo­li­tion of ex­ist­ing suites and the en­gi­neer­ing, in­stal­la­tion and val­i­da­tion of new equip­ment.

Then, in May of this year, the British phar­ma worked out a $231 mil­lion deal with CD­MO Sam­sung Bi­o­log­ics to out­source pro­duc­tion of its bi­o­log­ic prod­ucts, in­clud­ing Benlysta, over the next eight years. The deal will ini­tial­ly cov­er Benlysta, with the first com­mer­cial sup­ply ex­pect­ed in 2022. Benlysta gen­er­at­ed sales of $747 mil­lion in 2019, prop­ping up an oth­er­wise mea­ger bi­o­log­ics port­fo­lio for the Big Phar­ma. The drug pulled in $252 mil­lion in sales in the third quar­ter, putting it on pace to hit the block­buster mark.

Mean­while, chal­lengers from Roche and Au­rinia are rac­ing to­ward the mar­ket in lu­pus, pos­ing an ex­is­ten­tial chal­lenge to Benlysta’s hold on the hard-to-win mar­ket.

In June 2019, Roche post­ed Phase II da­ta show­ing blood can­cer med Gazy­va on top of stan­dard-of-care ther­a­py best­ed stan­dard of care alone in achiev­ing com­plete re­nal re­sponse for lu­pus nephri­tis pa­tients. The drug earned the FDA’s break­through tag back in Sep­tem­ber 2019. An­oth­er chal­lenger, Au­rinia’s late-stage lu­pus nephri­tis can­di­date vo­closporin, faces an FDA re­view date of Jan. 22, mak­ing it the ear­li­est po­ten­tial chal­lenger to GSK’s newest in­di­ca­tion.

For the second time in January and the third time in the last two months, a Kansas City, MO laboratory has pulled a lot of generic metformin from the shelves after it was found to contain higher-than-allowed levels of a probable human carcinogen.

The FDA on Tuesday announced that Nostrum Laboratories was voluntarily recalling a lot of metformin HCl extended release tablets, USP 750 mg, a type 2 diabetes drug (the generic equivalent to Glucophage tablets) after testing discovered elevated levels of nitrosamine, the probable carcinogen.

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.