Women ex­pel on av­er­age about 2 to 3 ta­ble­spoons of blood dur­ing their time of the month. But with uter­ine fi­broids, heavy bleed­ing is typ­i­cal — a third of a cup or more. Drug­mak­ers have been work­ing on oral ther­a­pies to try and stem the flow, and as ex­pect­ed, Ab­b­Vie and their part­ners at Neu­ro­crine Bio­sciences are the first to make it across the fin­ish line.

Known chem­i­cal­ly as elagolix, the drug is al­ready ap­proved as a treat­ment for en­dometrio­sis un­der the brand name Orilis­sa. It tar­gets the GnRH re­cep­tor to de­crease the pro­duc­tion of es­tro­gen and prog­es­terone.

Now, elagolix in com­bi­na­tion with two hor­mone drugs — estra­di­ol and norethin­drone ac­etate — has been ap­proved by the FDA. Ab­b­Vie will sell the twice-dai­ly reg­i­men as Ori­ahnn.

Mean­while, com­peti­tors such as My­ovant and Ob­sE­va al­so have ri­val oral GnRH re­cep­tor an­tag­o­nists wait­ing in the wings.

Char­lotte Owens, Ab­b­Vie

“In the ab­sence of head-to-head com­par­isons … it’s re­al­ly hard for us to com­pare and con­trast with drugs that are cur­rent­ly in de­vel­op­ment right now,” said Char­lotte Owens, med­ical di­rec­tor of gen­er­al med­i­cine at Ab­b­Vie, in an in­ter­view.

Ori­ahnn’s ap­proval was based on two six-month piv­otal stud­ies — each study re­quired the reg­i­men to gen­er­ate a sta­tis­ti­cal­ly sig­nif­i­cant im­pact on re­duc­ing blood loss by at least 50% in pa­tients. Each study al­so had an elagolix monother­a­py arm.

In one late-stage study, 68.5% (p<0.001) of elagolix com­bo-treat­ed women with uter­ine fi­broids hit that goal com­pared to place­bo (8.7%), in the sec­ond tri­al 76.2% elagolix com­bo-treat­ed women achieved the end­point com­pared to place­bo (10.1%). How­ev­er, the drug’s side ef­fect pro­file caused pause large­ly due to the loss of bone den­si­ty in pa­tients who re­ceived the Ab­b­Vie drug.

An­a­lysts have sug­gest­ed the Ob­sE­va and My­ovant ther­a­pies could have an edge over the Ab­b­Vie drug, if ap­proved.  But the two ri­vals will have been beat­en to mar­ket and nei­ther have the com­mer­cial prowess that a be­he­moth like Ab­b­Vie can boast of.

Ob­sE­va has test­ed its GnRH drug lin­zagolix in pa­tients with and with­out ABT. Late last year, the Swiss drug­mak­er post­ed da­ta from the PRIM­ROSE 2 tri­al, which test­ed two dos­es of the drug against a place­bo. The re­sults showed 93.9% for women re­ceiv­ing 200 mg of the drug with ABT tri­al saw more than 50% re­duc­tion in bleed­ing, and 56.7% for women re­ceiv­ing 100 mg with­out ABT achieved the same goal, com­pared to 29.4% in the place­bo group.

Al­though an­a­lysts have been en­cour­aged by the pos­i­tive da­ta in pa­tients who re­spond­ed well to the drug de­spite the lack of ABT (women pre­dis­posed to high BMI, CV risk and di­a­betes are typ­i­cal­ly not pre­scribed ABT) in the drug’s safe­ty pro­file, par­tic­u­lar­ly bone den­si­ty loss, did vex in­vestors. The com­pa­ny has an­oth­er piv­otal study that is ex­pect­ed to read out in the com­ing months.

Mean­while, My­ovant Sci­ences is al­so in the mix with its of­fer­ing: re­l­u­golix. The drug, like the Ab­b­Vie reg­i­men, is de­signed for use in com­bi­na­tion with ABT. Cur­rent­ly un­der FDA re­view, the reg­i­men was al­so test­ed in two phase III stud­ies, with the same main goal: 50% or more re­duc­tion in blood loss.

In one study, 71.2% of women re­ceiv­ing re­l­u­golix reg­i­men achieved the clin­i­cal re­sponse they were look­ing for, com­pared to on­ly 14.7% in the con­trol arm. In the oth­er, 73.4% of women on the re­l­u­golix arm achieved the same goal, com­pared with 18.9% of women re­ceiv­ing place­bo.  Cru­cial­ly, though, My­ovant’s did no sig­nif­i­cant dif­fer­ences in terms of bone min­er­al den­si­ty.

“The re­sponse rates demon­strat­ed in these tri­als were com­pa­ra­ble to those shown by Ab­b­Vie’s ap­proved GnRH in­hibitor, Orilis­sa, while main­tain­ing a sta­ble bone min­er­al den­si­ty pro­file with a once-dai­ly op­tion,” Baird’s Bri­an Sko­r­ney wrote in a note ear­li­er this month.

End­points News has con­tact­ed Ab­b­Vie for com­ment on Ori­ahnn pric­ing.

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.