Glax­o­SmithK­line’s Benlysta isn’t alone in the small cir­cle of ap­proved lu­pus nephri­tis drugs any­more.

Lit­tle Au­rinia Phar­ma­ceu­ti­cals has got­ten the green light from the FDA to start mar­ket­ing its first and on­ly pro­gram, vo­closporin, un­der the brand name Lup­ky­nis — some­thing CEO Pe­ter Green­leaf says it’s been ready to do since De­cem­ber.

Reg­u­la­tors went right down to the wire on the de­ci­sion, keep­ing the com­pa­ny and the en­tire sales­force it’s al­ready as­sem­bled on its toes.

Pe­ter Green­leaf

But they haven’t been idle. In an ear­li­er in­ter­view, Green­leaf told End­points News that the field team, which to­tals about 100 to 150 sales reps, has al­ready start­ed talk­ing to physi­cians about LN and go­ing to med­ical meet­ings to present da­ta on vo­closporin. By block­ing cal­cineurin, a sig­nal­ing pro­tein in­volved in T cell ac­ti­va­tion, the small mol­e­cule oral drug is de­signed to in­hib­it IL-2 and tamps down in­flam­ma­tion in the kid­ney.

The Phase III tri­al, AU­RO­RA, vo­closporin plus my­cophe­no­late mofetil and low-dose cor­ti­cos­teroids hit the pri­ma­ry end­point on re­nal re­sponse at 1-year. It al­so hit the bar for get­ting pro­tein­uria, a mea­sure­ment of ac­tive dis­ease, un­der con­trol.

“I mean, that’s the num­ber 1 treat­ment goal that physi­cians search for,” Green­leaf said.

First an­nounced in late 2019, those re­sults were sev­en years in the mak­ing for CMO Neil Solomons, who was part of a team at Vi­for Phar­ma that brought in vo­closporin from Isotech­ni­ka — it was be­ing de­vel­oped for kid­ney trans­plant re­jec­tion at that time — and spun out Au­rinia. Even though a pre­vi­ous study he was in­volved in had ce­ment­ed my­cophe­no­late mofetil, or MMF, among oth­er un­ap­proved meds as the stan­dard of care, there was re­al­ly no di­rect ev­i­dence of their treat­ment ef­fect (They were al­so “high­ly tox­ic,” ac­cord­ing to a tri­al in­ves­ti­ga­tor.)

Neil Solomons

“We’re the first com­pa­ny to do that,” Solomons said, “ran­dom­ized blind­ed con­trolled study with our Phase II tri­al back in 2016 to ac­tu­al­ly demon­strate that the drug ac­tu­al­ly tru­ly works in this area.“

Al­so among the firsts: a patent­ed dos­ing pro­to­col that al­lows pa­tients to titrate down the dose based on an es­ti­mate of re­nal func­tion known as eGFR, and re­duc­tion of cor­ti­cos­teroids re­quired in the reg­i­men.

All of those qual­i­ties, the com­pa­ny reck­ons, could give its reps plen­ty to con­vince doc­tors to take on their drug.

Green­leaf added that vo­closporin “works very very rapid­ly,” show­ing ben­e­fit at both the 6-month and 1-year time points that seems com­pa­ra­ble to — with the usu­al caveats about cross-tri­al com­par­isons — what Benlysta, a bi­o­log­ic, showed at 2 years.

“Who knows what that means for fu­ture treat­ment — how they’re used along­side of each oth­er, in con­cert or with­in the full treat­ment con­tin­u­um,” the CEO, who’s run a trio of oth­er biotechs af­ter leav­ing As­traZeneca’s Med­Im­mune, said. “But to­day as it ex­ists we think our drug stands very well on its own.”

By their count, the LN pa­tient pop­u­la­tion in the US is well north of 100,000. With $400 mil­lion in cash, Au­rinia’s $AUPH com­mer­cial team will have am­ple fund­ing for sev­er­al years. Ot­su­ka, its new part­ner, is tasked with scor­ing OKs and com­mer­cial­iz­ing in the EU, Japan and else­where.

Joseph Schwartz of SVB Leerink is a be­liev­er. While GSK may have the up­per hand at launch, he wrote, vo­closporin should even­tu­al­ly “come out on top, as it has su­pe­ri­or ef­fi­ca­cy as com­pared to Benlysta”: Au­rinia re­port­ed a re­nal re­sponse rate of 40.8% ver­sus 22.5% in the con­trol arm while Benlysta’s dif­fer­ence with con­trol was small­er (43% vs 32%).

For 2021, he’s mod­el­ing US sales at $87.6 mil­lion as­sum­ing a price of $35,000.

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.