Lynn Seely, Myovant CEO (Myovant)

In ground­break­ing move, FDA ap­proves My­ovan­t's re­l­u­golix as the first once-a-day pill for ad­vanced prostate can­cer

My­ovant Sci­ences $MY­OV won’t be get­ting coal in their stock­ing this Christ­mas.

The Swiss biotech, for­mer­ly part of the Vivek Ra­maswamy fam­i­ly of Vants, won FDA ap­proval of its re­l­u­golix drug on Fri­day af­ter­noon for the treat­ment of ad­vanced prostate can­cer. It’s the first oral hor­mone ther­a­py ap­proved for the in­di­ca­tion, reg­u­la­tors said, and the drug will be mar­ket­ed as Or­govyx. PDU­FA ac­tion had been sched­uled for Dec. 20.

Or­govyx will be priced at $2,300 per month, CEO Lynn Seely told End­points News on Mon­day.

In­vestors briefly cheered the green light, send­ing shares up rough­ly 7% im­me­di­ate­ly af­ter the ap­proval. But My­ovant’s stock slid back to its pre­vi­ous lev­els and sat down about 5% lat­er Fri­day.

With the risk im­muno­sup­pressed can­cer pa­tients face in the wake of the Covid-19 pan­dem­ic, the agency high­light­ed pa­tients’ abil­i­ty to take Or­govyx at home as a ben­e­fit for the drug. The stan­dard of care in this field, Ab­b­Vie’s Lupron, needs to be in­ject­ed once every three months, and oth­er treat­ments typ­i­cal­ly are placed as im­plants un­der the skin.

Richard Paz­dur

Or­govyx al­so “may elim­i­nate some pa­tients’ need to vis­it the clin­ic for treat­ments that re­quire ad­min­is­tra­tion by a health­care provider,” FDA on­col­o­gy chief Richard Paz­dur said in a state­ment.

Seely said, how­ev­er, that she be­lieved the ben­e­fits can help the drug stand out on its own, with or with­out a pan­dem­ic.

“We know from our re­search that the ma­jor­i­ty of men pre­fer an oral treat­ment to an in­jec­tion,” Seely said. “Now, all that be­ing said, with the Covid-19 pan­dem­ic, there is a rec­om­men­da­tion from the Na­tion­al Com­pre­hen­sive Can­cer Net­work for pa­tients with can­cer to avoid hos­pi­tals and clin­ics as much as pos­si­ble. It’s, we be­lieve, one of the rea­sons we were grant­ed pri­or­i­ty re­view by the FDA.”

Fri­day’s ap­proval came on the ba­sis of a Phase III study from back in No­vem­ber 2019, which pit­ted Or­govyx head-to-head with Lupron in men with prostate can­cer. The idea be­hind the pro­gram is cen­tered around testos­terone pro­duc­tion — be­cause prostate can­cer is fu­eled by the hor­mone, My­ovant had sought to cut testos­terone lev­els to a point that would qual­i­fy as med­ical cas­tra­tion.

The pri­ma­ry end­point in that study showed 96.7% of men treat­ed with Or­govyx achieved sus­tained testos­terone sup­pres­sion over 48 weeks, com­pared to 88.8% on Lupron. Reg­u­la­tors had set a bench­mark of at least 90% clear­ance, CEO Lynn Seely told End­points News at the time.

Ap­proval came de­spite Or­govyx whiff­ing bad­ly on a key sec­ondary end­point when fur­ther da­ta came out in Sep­tem­ber, as the drug fared nu­mer­i­cal­ly worse in cas­tra­tion re­sis­tance-free sur­vival af­ter 48 weeks than Lupron. In the sub­group of men with metasta­t­ic prostate can­cer, 74% of those treat­ed with Or­govyx were alive and cas­tra­tion-re­sis­tance free through 48 weeks, com­pared to 75% on Lupron.

The p-val­ue of the end­point was p=0.84, and My­ovant shares were crushed by 25% at the time.

No­tably, how­ev­er, Or­govyx man­aged to beat out Lupron on ma­jor car­dio­vas­cu­lar events, show­ing a 2.9% rate against the Ab­b­Vie drug’s 6.2% rate. The su­pe­ri­or­i­ty in these safe­ty events is a big rea­son why SVB Leerink an­a­lyst Ami Fa­dia says My­ovant can po­si­tion Or­govyx as a more ap­peal­ing op­tion to physi­cians.

As a go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist, Or­govyx works by block­ing the re­cep­tor, an ap­proach that con­trasts with Lupron. The Ab­b­Vie drug de­sen­si­tizes the re­cep­tor by hit­ting it re­peat­ed­ly.

Prostate can­cer is one of three in­di­ca­tions in which My­ovant has prepped ap­proval pack­ages for both the FDA and EMA. The oth­er fields are uter­ine fi­broids, with a PDU­FA date set for next June 1, and en­dometrio­sis, where the com­pa­ny is plan­ning NDA and Eu­ro­pean sub­mis­sions for the drug lat­er in 2021. Or­govyx us­es the same path­way to low­er testos­terone in men as it does to low­er es­tro­gen and prog­es­terone in women.

Ab­b­Vie isn’t con­tent to let by­gones be by­gones, how­ev­er, as it’s been prep­ping a Lupron suc­ces­sor for some time. Back in May, the FDA ap­proved the com­pa­ny’s elagolix in com­bi­na­tion with two hor­mone drugs, estra­di­ol and norethin­drone ac­etate, for uter­ine fi­broids. My­ovant is look­ing at us­ing Or­govyx in com­bi­na­tion with ABT in that field, and saw 50% or more re­duc­tion in blood loss in two Phase III stud­ies, sim­i­lar to Ab­b­Vie’s ap­proach.

My­ovant com­pa­ny is al­so ex­pect­ed to ap­proach Eu­ro­pean reg­u­la­tors for ap­proval in prostate can­cer in the first half of next year.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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