Su­per­nus' non­stim­u­lant AD­HD drug Qel­bree gains ap­proval for adult use

Up to 90% of the chil­dren that are di­ag­nosed with at­ten­tion deficit hy­per­ac­tiv­i­ty dis­or­der re­tain the di­ag­no­sis in­to adult­hood. Now, those adults will have an­oth­er non­stim­u­lant op­tion for treat­ment, as the FDA ap­proved an ex­pand­ed in­di­ca­tion for the use of Su­per­nus Phar­ma­ceu­ti­cals’ prod­uct in adults.

The drug, Qel­bree, is now ap­proved for every­one above the age of 6 di­ag­nosed with AD­HD. There are rough­ly 16 mil­lion peo­ple in the US with the dis­or­der.

Qel­bree is tak­en once dai­ly, and showed no ev­i­dence of abuse in clin­i­cal stud­ies. The non­stim­u­lant is the first ap­proval of its kind in 20 years. The dai­ly flex­i­ble dose is be­tween 200 mg and 600 mg, and showed sig­nif­i­cant im­prove­ment in the adult AD­HD In­ves­ti­ga­tor Symp­tom Rat­ing Scale (AISRS) score, with a p-val­ue of 0.0040.

Jack Khat­tar

“As a leader in the field of CNS, we are ful­ly com­mit­ted to bet­ter un­der­stand­ing how to treat com­plex dis­eases such as AD­HD,” Su­per­nus CEO Jack Khat­tar said in a state­ment. “To­day’s ap­proval marks a ma­jor ad­vance­ment in the treat­ment of AD­HD and is an im­por­tant mile­stone just one year af­ter the ap­proval of Qel­bree to treat pe­di­atric pa­tients. We are proud to bring a new nov­el non­stim­u­lant op­tion for adults in­to the mar­ket af­ter two decades.”

Qel­bree was first ap­proved for the use in chil­dren be­tween the age of 6 and 17 around this time last year. Reg­u­la­tors first re­ject­ed the ap­pli­ca­tion in No­vem­ber 2020, due to CMC is­sues af­ter the re­lo­ca­tion of an in-house lab that raised ques­tions about qual­i­ty con­trol.

It was a long jour­ney to ap­proval for the Su­per­nus team. Back in 2018, the Phase III da­ta fell flat, af­ter Qel­bree failed to show a dose-de­pen­dent re­sponse. In­vestors wor­ried that it would be dif­fi­cult to dif­fer­en­ti­ate the drug from Eli Lil­ly’s Strat­tera and Shire’s In­tu­niv.

“Un­til to­day, non­stim­u­lant AD­HD op­tions for adults have been very lim­it­ed,”  Greg Mat­ting­ly, co-founder of St. Charles Psy­chi­atric As­so­ci­ates, said in a state­ment. “This ap­proval is pos­i­tive news and of­fers a new nov­el op­tion for the mil­lions of Amer­i­can adults who are try­ing to find the right treat­ment to man­age their AD­HD symp­toms.”

The ap­proval for chil­dren did come with a warn­ing, though, and the adult ap­proval mir­rored it.

Qel­bree may in­crease sui­ci­dal thoughts and ac­tions, in chil­dren and adults with AD­HD, es­pe­cial­ly with­in the first few months of treat­ment or when the dose is changed. Tell your doc­tor if you have (or if there is a fam­i­ly his­to­ry of) sui­ci­dal thoughts or ac­tions be­fore start­ing Qel­bree. Mon­i­tor your moods, be­hav­iors, thoughts, and feel­ings dur­ing treat­ment with Qel­bree. Re­port any new or sud­den changes in these symp­toms right away. Qel­bree should not be tak­en by pa­tients that al­so take cer­tain an­ti-de­pres­sion med­i­cines, es­pe­cial­ly those called a monoamine ox­i­dase in­hibitor or MAOI, or cer­tain asth­ma med­i­cines.

Back in 2020, Su­per­nus forked over $300 mil­lion to grab the CNS port­fo­lio of US WorldMeds. With that, it picked up Apokyn, My­obloc and Xada­go. In ad­di­tion to AD­HD, the bio­phar­ma has drugs for epilep­sy, mi­graines and Parkin­son’s dis­ease in its port­fo­lio.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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