Re­gen­eron’s an­ti-VEGF Eylea has long dom­i­nat­ed its mar­ket, but com­peti­tors are look­ing to de­throne the king — par­tic­u­lar­ly No­var­tis’ late­com­er Beovu. Ham­pered by pri­or safe­ty con­cerns, No­var­tis has set Eylea di­rect­ly in its sights with a pair of non-in­fe­ri­or­i­ty stud­ies for Beovu that could help it get over the line in mac­u­lar ede­ma.

No­var­tis’ Beovu matched Re­gen­eron’s an­ti-VEGF Eylea a year af­ter treat­ment at im­prov­ing di­a­bet­ic mac­u­lar ede­ma pa­tients’ eye­sight in the drug’s sec­ond head-to-head swing at the mar­ket leader, No­var­tis said Tues­day.

In the Phase III Kestral tri­al — a com­ple­ment to the pri­or Kite study — pa­tients re­ceiv­ing a 6-mg dose of Beovu every three months saw sim­i­lar im­prove­ments in eye­sight, in­clud­ing cen­tral sub­field thick­ness, com­pared with pa­tients dosed with 2 mgs of Eylea, No­var­tis said.  In a 12-week fol­low-up pe­ri­od, Beovu con­tin­ued to match Eylea’s re­sults in im­prov­ing pa­tients’ eye­sight.

The top-line Kestral re­sults come with­in months of the ear­ly Kite study read­out, which al­so showed Beovu matched Eylea’s ef­fi­ca­cy in di­a­bet­ic mac­u­lar ede­ma. Eylea is the easy mar­ket leader in mac­u­lar ede­ma, where Beovu is cur­rent­ly chas­ing an FDA ap­proval. No­var­tis’ drug hit the mar­ket back in Oc­to­ber 2019, scor­ing an FDA ap­proval in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD).

Chas­ing Eylea and its $1.32 bil­lion in third-quar­ter sales will be no easy task for No­var­tis, par­tic­u­lar­ly af­ter an un­for­tu­nate Beovu la­bel up­date back in Sep­tem­ber added in­for­ma­tion on reti­nal vas­culi­tis and reti­nal vas­cu­lar oc­clu­sion, which can cause blind­ness. It’s not quite a black-box warn­ing, but it could be enough to de­ter physi­cians will­ing to give the new­er drug a shot; No­var­tis has said it’s con­vened a pan­el of ex­perts to ex­am­ine the prob­lem.

In the mean­time, the Swiss phar­ma said there were no new safe­ty sig­nals in the Kestral study, back­ing up its sta­ble safe­ty da­ta from the Kite study. Both Beovu and Re­gen­eron are de­liv­ered by in­trav­it­re­al in­jec­tion di­rect­ly in­to the eye.

On top of its pur­suit of mac­u­lar ede­ma, No­var­tis is al­so hop­ing to take Beovu in­to reti­nal vein oc­clu­sion and pro­lif­er­a­tive di­a­bet­ic retinopa­thy as it hunts a mar­ket Eylea has long dom­i­nat­ed. The drug snared $51 mil­lion in sales in the third quar­ter and has bagged ap­provals in 46 coun­tries as of Sep­tem­ber.

Pri­or to the new safe­ty flags, No­var­tis tout­ed Beovu’s less oner­ous dos­ing reg­i­men, which re­quires month­ly in­jec­tions for the first three months of treat­ment be­fore switch­ing over to a once-every-12-weeks sched­ule. Eylea, mean­while, re­quires the month­ly in­jec­tion through month three with fol­low-up in­jec­tions need­ed every eight weeks.

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.

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.”