By writer to www.evaluate.com
After virtually a yr grappling with the coronavirus pandemic an important job for US regulators subsequent month will probably be reviewing the primary Covid-19 vaccines. Biontech and Pfizer’s undertaking will probably be mentioned at a panel on December 10, and whereas a date has but to be set formally for Moderna to current its candidate a December 17 adcom has been rumoured.
Each vaccines reported spectacular topline efficacy earlier this month. The panel hearings ought to see extra granular information, and permit a greater evaluation of the initiatives’ security profiles. The FDA is predicted to grant each vaccines swift emergency use authorisations.
Aside from Covid-19, the FDA has a number of essential selections left to make this yr, however manufacturing inspection delays owing to pandemic journey restrictions have hit some recent approvals. The problem may lengthen timelines for Novartis’s lipid-lowering undertaking Leqvio, which has a December Pdufa date (Novartis’s big wager on RNAi approaches the finish line, November 25, 2020).
Elsewhere, questions stay round Astra and Fibrogen’s anaemia capsule Evrenzo, due an approval determination by December 20. The novel anaemia remedy demonstrated noninferiority to erythropoiesis-stimulating brokers (ESAs) in dialysis-dependent sufferers, and noninferiority to placebo in non-dialysis sufferers, throughout an unlimited pivotal programme.
Nevertheless, the builders have been criticised for the way the results were presented, significantly on the vital challenge of cardiac security. Since then, Akebia’s vadadustat, like Evrenzo a hypoxia-inducible issue prolyl hydroxylase inhibitor, has been hit by cardiac safety worries, presumably pointing to a category have an effect on. Akebia is urgent on, nonetheless, and a submitting for the undertaking is predicted subsequent yr.
The FDA’s verdict on Evrenzo is tough to name, although the dearth of an advisory committee assembly may enhance confidence. A significant concern is whether or not the company will insist on a black field warning about elevated threat of cardiovascular points, just like these with ESAs.
On the current Stifel healthcare convention Fibrogen famous that the affect of a black field warning would possible be modest in dialysis-dependent sufferers, as ESAs have already got a warning. In non-dialysis dependent sufferers, lower than 15% of whom obtain anaemia remedy, adoption of Evrenzo may very well be slower because the notion of security could be affected.
Relugolix’s first go of the US regulators, in prostate most cancers, is due on December 20. The oral GnRH receptor antagonist, trademarked Relumina, is Myovant’s lead asset. Myovant is already half owned by Sumitomo, and a few buyers maintain out hope that approval will persuade the Japanese firm to purchase Myovant outright (Sumitomo takes out Urovant, and Myovant beckons, November 13, 2020).
Nevertheless, questions stay after Relumina’s pivotal Hero research produced combined outcomes. The undertaking met the primary endpoint of testosterone suppression versus leuprolide, the established androgen-deprivation remedy, but additionally failed to show superiority in castration resistance-free survival.
Supporters of the inventory have been eager to level out that the prevalence endpoint was a secondary measure, and relugolix beat leuprolide on security, displaying a 54% decrease threat of main hostile cardiovascular occasions.
Buyers should wait till the center of subsequent yr for relugolix’s Pdufa in uterine fibroids, the undertaking’s most profitable indication. Over half of the drug’s $721m forecast 2026 gross sales are assigned to uterine fibroids, with simply $174m in prostate most cancers and the rest in endometriosis, the place the undertaking is in part III.
Behind the competitors
Macrogenics’ margetuximab has a choice date of December 18 however the Her2-targeting antibody has struggled to outshine rivals. Knowledge from the Sophia trial in third and fourth-line Her2-positive metastatic breast most cancers confirmed an ORR of just 22.1%, and there was no survival benefit over Herceptin. A last OS evaluation of Sophia is due within the second half of subsequent yr.
Astrazeneca and Daiichi’s antibody-drug conjugate Enhertu was granted accelerated approval final December after displaying a 60.3% response fee in closely pretreated breast most cancers sufferers. These corporations at the moment are going after earlier settings, and the continuing Destiny-Breast 02 research pits Enhertu in opposition to Herceptin and chemotherapy in those that have progressed on Roche’s Kadcyla.
Consensus gross sales forecasts present which undertaking sellside analysts are backing: margetuximab is predicted to hit $277m in breast most cancers gross sales by 2026 versus Enhertu’s blockbuster-level forecast of $3.5bn.
The tables under listing first-time and supplementary US approvals in addition to panel conferences due subsequent month, with consensus forecasts from EvaluatePharma.
|Advisory committee conferences in December|
|Venture||Firm||Adcom date||2026e gross sales by indication ($m)||Notice|
|BNT162b2||Pfizer/Biontech||Dec 10||609||Covid-19 vaccine|
|Entresto||Novartis||Dec 15||4,030*||sNDA for coronary heart failure with preserved ejection fraction|
|*SBI information not cut up out. Supply: FDA adcom calendar & EvaluatePharma.|
|Notable first-time US approval selections due in December|
|Venture||Firm||PDUFA date||2026e gross sales by indication ($m)||Notice|
|Leqvio (inclisiran)||Novartis||Dec||2,008||Novartis’s big wager on RNAi approaches the finish line|
|Brixadi||Camurus/ Braeburn||Dec 1
|–||Remedy of opioid use dysfunction|
|Biocryst||Dec 3||382||Prevention of hereditary angioedema assaults|
|Margetuximab||Macrogenics||Dec 18||277||See textual content|
|Relumina (relugolix)||Myovant||Dec 20||174||See textual content|
|Dec 20||1,845||See textual content|
|Vibegron||Urovant (Sumitomo Dainippon)||Dec 26||425||Overactive bladder|
|Osmotica||Dec 29 (resubmission)||64||MS spasticity|
|Furoscix||Scpharmaceuticals||Dec 30 (resubmission)||–||Worsening coronary heart failure resulting from congestion|
|Athenex/Almirall||Dec 30||133||Actinic keratosis|
|Dostarlimab||GSK||By YE||571||Anti-PD-1 filed in endometrial most cancers|
|Sources: EvaluatePharma & firm releases.|
|Supplementary and different notable approval selections in December|
|Product||Firm||Indication (scientific trial)||Date|
|Bijuva||Therapeuticsmd||0.5mg/100mg dose for menopause (Replenish)||Estimated December|
|Hetlioz||Vanda||Hetlioz capsules and liquid formulation used to deal with Smith-Magenis Syndrome (pivotal Ph2/3 information)||Dec 1|
|Ocrevus||Roche||Two-hour infusion , dosed twice yearly for relapsing or major progressive MS (Ensemble Plus)||Dec 14|
|Amgen/ Abbvie||CD20-positive B-cell NHL, CLL, RA (NCT02792699, Jasmine)||Dec 19|
|Biocon/ Mylan||1L and 2L met colorectal most cancers (+ fluorouracil-based chemo); 1L non-squamous NSCLC; recurrent glioblastoma; met renal cell carcinoma (+ interferon alfa); and protracted, recurrent or met cervical most cancers||Dec 27|
|Trikafta, Symdeko, Kalydeco||Vertex||To incorporate extra uncommon CFTR mutations in cystic fibrosis (based mostly on in vitro information)||Dec 30|
|Xolair||Novartis/ Roche||Nasal polyps (Polyp 1 and 2)||This fall|
|Sources: EvaluatePharma & firm releases.|
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