Where Te­va failed, Eli Lil­ly gained — mi­graine drug Em­gal­i­ty wins US ap­proval for episod­ic clus­ter headaches

It may be trail­ing be­hind its ri­vals in mi­graine sales, but Lil­ly’s Em­gal­i­ty has se­cured the FDA nod for episod­ic clus­ter headaches.

Em­gal­i­ty was the last in­jectable to win ap­proval for mi­graine pre­ven­tion last Sep­tem­ber, months af­ter Aimovig from Am­gen $AMGN  and No­var­tis $NVS, and Te­va’s {$TE­VA] Ajovy. All three form part of a fam­i­ly of drugs de­vel­oped to block cal­ci­tonin gene-re­lat­ed pep­tide (CGRP), a pro­tein as­so­ci­at­ed with the on­set of mi­graine pain. Each has demon­strat­ed a sig­nif­i­cant re­duc­tion in mi­graine fre­quen­cy in about half of pa­tients when test­ed in clin­i­cal stud­ies and is priced at $6,900 a year, or $575 per month. Tiny Alder’s $AL­DR CGRP is un­der FDA re­view.

In March, Em­gal­i­ty was grant­ed pri­or­i­ty re­view by the FDA for pre­ven­tion of episod­ic clus­ter headache in adults. The fol­low­ing month, Te­va aban­doned a late-stage tri­al test­ing Ajovy for episod­ic clus­ter headaches af­ter the drug failed to clear a fu­til­i­ty test, af­ter giv­ing up on a chron­ic clus­ter headache study last sum­mer. The Is­raeli drug­mak­er is still test­ing the drug for post-trau­mat­ic headaches.

Em­gal­i­ty was ap­proved on the ba­sis of da­ta from a 106-pa­tient place­bo-con­trolled study. In the tri­al, pa­tients on Em­gal­i­ty ex­pe­ri­enced an av­er­age of 8.7 few­er week­ly clus­ter headache at­tacks be­tween weeks 1 to 3 ver­sus 5.2 few­er week­ly at­tacks for pa­tients on place­bo (p=0.036). With Em­gal­i­ty, 71.4% of pa­tients had their week­ly clus­ter headache at­tacks cut in half or more from base­line at week 3 vs. 52.6% of pa­tients with place­bo (p=0.046).

“The op­por­tu­ni­ty in this pop­u­la­tion, which we es­ti­mate to be ~200,000 pa­tients in the US, could add to Lil­ly’s com­pet­i­tive ad­van­tage against Am­gen and Te­va,” Leerink an­a­lysts wrote in a note in April.

Af­flict­ed pa­tients ex­pe­ri­ence ex­cru­ci­at­ing headache at­tacks de­scribed some­times as “sui­cide headaches” be­tween 1-8 times per day, and these clus­ter cy­cles can last weeks or months and are usu­al­ly sep­a­rat­ed by headache-free re­mis­sion pe­ri­ods, which typ­i­cal­ly last months or years.

While the mi­graine dose is 120 mg, pa­tients pre­scribed Lil­ly’s $LLY Em­gal­i­ty for clus­ter headaches will be ad­min­is­tered a 300 mg dose at the on­set of a clus­ter pe­ri­od, fol­lowed by sub­cu­ta­neous in­jec­tions each month un­til the end of the pe­ri­od. The price per mg for Em­gal­i­ty re­mains the same, Lil­ly said.

In the first quar­ter of 2019, Aimovig gen­er­at­ed sales of $59 mil­lion, Ajovy brought in $20 mil­lion, while Em­gal­i­ty made $14 mil­lion.

The ap­proval comes as a wel­come re­lief for Lil­ly, which has suf­fered a string of set­backs in re­cent months — a late-stage fail­ure trig­gered the with­draw­al of its can­cer drug Lartru­vo, the US drug­mak­er rel­e­gat­ed two mid-stage drugs to the scrap heap, and Japan flagged safe­ty con­cerns as­so­ci­at­ed with its breast can­cer treat­ment, Verzenio.

Im­age: Kristof­fer Trip­plaar for SIPA AP

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