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.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.