Takeda to pull key hypoparathyroidism drug from the market entirely by end of 2024 after years of manufacturing woes – Endpoints News

Take­da on Tues­day morn­ing made an an­nounce­ment that al­most 3,000 peo­ple with the rare dis­ease known as hy­poparathy­roidism were fear­ing.
Due to un­re­solved sup­ply is­sues and man­u­fac­tur­ing woes, Take­da said it will cut its loss­es and dis­con­tin­ue its hy­poparathy­roidism drug, known as Nat­para (parathy­roid hor­mone), halt­ing all man­u­fac­tur­ing of the drug by the end of 2024.
The de­ci­sion to not re-com­mer­cial­ize Nat­para will be a blow to not on­ly the 2,400 peo­ple who were await­ing sup­plies of their re­li­able in­jec­tion since 2019, but al­so the ad­di­tion­al near­ly 400 peo­ple who were ac­cess­ing the drugs via the com­pa­ny’s Spe­cial Use Pro­gram as Take­da sought to re­solve these man­u­fac­tur­ing is­sues over the past five years.
Heather No­vak, an au­thor and hy­poparathy­roid pa­tient who has ac­cessed Nat­para via the Spe­cial Use Pro­gram, told End­points News via email:
Take­da did not com­mu­ni­cate with Spe­cial Use pa­tients di­rect­ly—and I’m dev­as­tat­ed and ter­ri­fied. While Acendis Phar­ma’s new PTH re­place­ment in­jec­tion, Transcon PTH, was sub­mit­ted to the FDA for ap­proval last month, un­less it’s rushed, the time­line goes per­fect­ly, and in­sur­ance ap­proves with­out hes­i­ta­tion, I do not be­lieve it will be a vi­able al­ter­na­tive for Spe­cial Use pa­tients to trans­fer to by 2024. This leaves over 400 peo­ple who can’t stop tak­ing a syn­thet­ic PTH hor­mone with­out life-threat­en­ing re­sults with­out op­tions.
The dif­fi­cul­ties with hy­poparathy­roidism oc­cur due to low lev­els of cal­ci­um in the blood. Symp­toms can range from the more mild tin­gling or numb­ness in the fin­gers and toes, to se­vere mus­cle cramps and spasms, as well as breath­ing is­sues that can lead to hos­pi­tal­iza­tion, ac­cord­ing to the Na­tion­al Or­ga­ni­za­tion for Rare Dis­or­ders.
And pa­tients have ex­plained to End­points News many of the com­pli­ca­tions that can arise when ac­cess is lost to Nat­para.

Ri­ta Mc­Cul­lough of Le Cen­ter, MN, told End­points via email in 2021 that with­in a week of the 2019 re­call, she end­ed up in the emer­gency de­part­ment twice. She said the con­di­tion af­fects her breath­ing and she has se­vere mus­cle spasms with­out Nat­para.
“I was crushed that I had to go back to all the pills and the alarm every two hours just so I can breathe,” she said, not­ing that Nat­para did work for her.
The is­sues and re­call in 2019 for Nat­para cen­tered on rub­ber par­tic­u­lates orig­i­nat­ing from the rub­ber sep­tum of the car­tridge. And based on com­ments from Take­da on Tues­day, those par­tic­u­late prob­lems were nev­er solved.
Take­da has con­tin­ued to com­mu­ni­cate up­dates about per­sis­tent sup­ply chal­lenges sur­round­ing pro­tein par­ti­cle for­ma­tion that are unique and spe­cif­ic to NAT­PAR/NAT­PARA. Over the past sev­er­al years, Take­da has ex­plored nu­mer­ous ways to ad­dress the NAT­PAR/NAT­PARA pro­tein par­ti­cle is­sue to im­prove sus­tain­able sup­ply. Some of the spe­cif­ic steps have in­clud­ed fo­cused root cause analy­sis, com­pu­ta­tion­al mod­el­ing, eval­u­a­tion and im­ple­men­ta­tion of man­u­fac­tur­ing process changes and re­for­mu­la­tion re­search and de­vel­op­ment. Sep­a­rate­ly, af­ter eval­u­a­tion of the U.S. Com­plete Re­sponse Let­ter re­ceived ear­li­er this year, Take­da de­ter­mined it can­not im­ple­ment a so­lu­tion to the rub­ber par­ti­cle for­ma­tion is­sue
Bob Sanders, chair­man of the board of the non­prof­it Hy­poparathy­roidism As­so­ci­a­tion, pre­vi­ous­ly told End­points that he isn’t aware of any­one who has died from a lack of ac­cess to Nat­para. He said some who have lost ac­cess to Nat­para are tak­ing Eli Lil­ly’s For­teo off-la­bel, while oth­ers are on cal­ci­um sup­ple­ments and Cal­citri­ol, which is not al­ways ap­proved by in­sur­ance com­pa­nies and can cre­ate fi­nan­cial bur­dens for some pa­tients.
“We all hope that there is no cal­ci­um crash as most hos­pi­tals lack the un­der­stand­ing to treat a hy­popara pa­tient be­cause it is so rare,” Sanders said.
Take­da ac­quired Nat­para when it bought out Shire for $62 bil­lion in ear­ly 2019. In 2018, the last full year of Nat­para sales, the treat­ment brought in about $230 mil­lion. Since the Nat­para re­call in Sep­tem­ber 2019, no US rev­enue has been record­ed.