Every New Year brings new drug approval hopefuls. However, anticipation is particularly high this year, given renewed optimism for success after a disastrous 2020.
Based on Evaluate consensus sales estimates, we’ve come up with the top 5 of the most anticipated drug launches of 2021. The candidates listed come with a lot of expectations, controversies, and pandemic-ending ambitions. There’s also one repeat. However, they all have huge potentials and are estimated to achieve heavyweight status by 2024 according to Evaluate.
Here they are:
Top of the list is the industry’s love-hate Alzheimer’s candidate Aducanumab from Biogen and Eisai. No other pending drug approval faces more skepticism on one side, and more support on the other, than Aducanumab. On one hand are hopeful Alzheimer’s patients, families and advocates, Biogen and Eisai, and some supporters inside the FDA. Their point is that a stake in the ground for Alzheimer’s is paramount, and while Aducanumab may not be a miracle drug, it’s a needed start. On the other hand are physicians, other Pharma companies with Alzheimer’s candidates and the majority of the FDA advisory panel that reviewed the drug – experts who disclosed they understand the dire need for a solution, but that Aducanumab is not effective enough to make a difference for Alzheimer’s patients.
The drug failed in its November AdComm with dismal testimony and a resounding 8-1 thumbs-down on whether the phase 3 trial offers ‘strong evidence that supports the effectiveness’ of the drug as a treatment for Alzheimer’s. Two members abstained. A second vote on whether a small phase 1B study showed “supportive evidence” for efficacy was almost as scathing with a 7-1 thumbs-down and four members abstaining.
However, Aducanumab came into the panel with a positive FDA briefing docs. So positive that most of the Advisory Committee members rebuked FDA officials for apparently lining up the drug for a rubberstamp approval. Going forward, Biogen and the rest of the world will need to wait even longer for a decision. Originally set for a final nay r yay in March, the FDA postponed its decision to early June in January. If approved, Evaluate estimates track a model 2021 start at $271 million in total sales and $765 million for 2022, but then anticipates the drug taking off and reaching $4.94 billion by 2026.
Novavax’s Covid-19 candidate, NVX-CoV2373 is number two on our list. The company went under the radar for the larger part of 2020 with its Covid-19 vaccine. While Pfizer and Moderna took the headlines, the small Maryland-based company took its Operation Warp Seed grant of $1.6 billion deposited after the first drugmakers cashed in – and launched late-stage clinical development including a 30,000-patient phase 3 study. In late January 2021, the drug showed 89% efficacy in its phase 3 U.K. trial and 60% in phase 2b trial in South Africa, with above 90% of those who partook in the study infected with the seemingly more infectious B.1.351 strain that was discovered there. Novavax is the first Pharma with significant trial data on the emerging variants – its clinical data add to a growing list of evidence that existing Covid-19 vaccines may be less effective against the B.1.351 strain. While virus variants will weigh on Novavax much like other vaccine makers, it’s already digging in with booster shot efforts to tackle likely mutations.
CEO Stanley Erck confirmed that Novavax is discussing with the FDA about the possibility of evaluating the vaccine based on its U.K. data, but doesn’t have a specific answer yet. The company anticipates the vaccine’s first approval to be in the U.K.
Efgartigimod from Argenx is on track to be the first to be approved within the anti-FcRn drug class, which according to analysts at SVB Leerink could achieve a market worth of $20 billion to $25 billion in the U.S. only by 2030. The Belgian firm recently submitted the drug in generalized myasthenia gravis (gMG) with the FDA and anticipates the same with regulatory agencies in the EU and Japan this year. With that timeline, the company believes it has an estimated three-year window versus a short list of other clinical FcRn competitors, which includes UCB, Alexion Pharmaceuticals (soon to be AstraZeneca) and Johnson and Johnson’s newly acquired Momenta Pharmaceuticals, among others.
FcRn is reputed as a protection receptor of immunoglobulin (IgG). The basis for drugs such as Efgartigimod is that blocking FcRn could decrease pathogenic IgG antibodies, which are causal agents in many autoimmune diseases.
Efgartigimod proved it could work in MG by improving the symptoms of a significantly bigger number of patients than placebo did in the phase 3 Adapt trial. Among patients who tested positive during the trial for acetylcholine receptor (AChR) antibody – an indicator of MG-67.7% of those on Efgartigimod were listed as responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, while only 29.7% placebo patients could say that. In terms of duration of treatment response, 56.8% of trial patients responded to Efgartigimod for at least eight weeks, and 34.1% at least 12 weeks. The trial also enlisted AChR-negative patients, and a secondary endpoint analysis of all-comers also achieved significance. However, as Argenx claimed an unusually high placebo response, SVB Leerink’s Thomas Smith, in a release in May, pointed to the possibility of the non-AChR subgroup not meeting statistical significance, suggesting the final FDA label could still be up for review. About 85% of MG patients are diagnosed with anti-AChR autoantibodies.
Argenx, like its FcRn rivals, is looking at a wide range of autoimmune indications. Across the entire class, these include chronic inflammatory demyelinating polyneuropathy, primary immune thrombocytopenia, thyroid eye disease, among others.
4. Bardoxolone methyl
Number four on our list is chronic kidney disease medication Bardoxolone methyl from Reata Pharmaceuticals. The drug has witnessed an eventful decade that began with an $850 million Abbott partnership between 2010 and 2011. However, clinical trial problems in investigations for the drug in Type 2 diabetes mellitus and stage 4 chronic disease occurred in 2012 leading to an abrupt halt in the studies. The company went back to the drawing board, reduced staff length by half and reviewed the drug’s potential use. In 2014, Reata pushed Bardoxolone into phase 2 development in a fresh indication, pulmonary arterial hypertension (PAH). The company also started testing the medication in two kinds of inherited kidney disease: Alport syndrome and autosomal dominant polycystic kidney disease, a genetic disorder in which many cysts grow in the kidneys. In the meantime, Abbott, which had turned to AbbVie, pulled out in 2019, selling its $850 million investment for $330 million in cash. Reata attributed the departure to changes in AbbVie moving away from kidney disease. Just a month later, and a year into its Alport Cardinal study, Reata reported positive phase 3 data in late 2019, showing that patients who were administered the drug had improved kidney function after 48 weeks of treatment and consistent improvement after halting usage for four weeks. At the two-year anniversary in November 2020, the company announced it had reached primary and key secondary endpoints in the Cardinal study and that it had finalized a pre-NDA meeting with the FDA with plans to submit a filing in the first quarter of 2021, while also starting work to file for approval in the EU.
Last on our list is Bristol Myers Squibb’s Deucravacitinib. Bristol Myers Squibb took on some risks when it resolved to keep investigational the TYK2 inhibitor but divest Celgene’s growing blockbuster Otezla to achieve U.S. antitrust clearance for the two companies’ megamerger. However, phase 3 results seem to show that the drugmaker made the right call. In November, 2020, the company reported that the med topped none other than Otezla in a phase 3 trial in patients with moderate to severe plaque psoriasis. More patients who received the new medication reported improved skin condition than those Otezla takers did. Then earlier this month, it trumped Otezla again in a second similar phase 3 study. Analysts believe a huge market awaits Deucravacitinib if Otezla could be a good indication. In the first nine months of 2020, the medication raked in $1.58 billion in sales after a 15% yearly growth, which was affected by Covid-19. Beyond psoriasis, Bristol Myers believes the TYK2 pathway could be aimed at in other inflammatory ailments such as psoriatic arthritis, lupus and inflammatory bowel disease. With respect to likely future rivals, Pfizer has a TYK2/JAK1 inhibitor known as brepocitinib, which is in phase 2 development in both oral and topical formulations across a wide range of indications. However, SVB Leerink analysts previously suggested that deucravacitinib’s phase 2 showing could be difficult for Pfizer to trump, and the firm is about two years behind Bristol Myers.