Potential Blockbuster Approvals in 2019

Four forecast as having $1 billion in sales by 2023
 
ClarivateAnalytics™ in its Cortellis™ Drugs to Watch 2019 report published a forecast of four drugs that may be approved in the U.S. in 2019, which they forecast as having $1 billion in sales by 2023. All four drugs have been designated Orphan Drugs. In addition, there are three drugs with breakthrough status and two have Fast Track status. The four drugs are being developed to treat a variety of diseases, but surprisingly none are oncology drugs.

1. AbbVie’s updacitinib, a JAK1 inhibitor being developed for rheumatoid arthritis, atopic dermatitis, Crohn’s disease, and juvenile idiopathic arthritis. Updacitinib will compete with the already approved JAK inhibitors tofacitinib (Xeljanz, Pfizer) and baricitinib (Olumiant, Eli Lilly) in addition to tumor necrosis factor (TNF) blockers (etanercept, golimumab, infliximab) and non-TNF biologicals (tocilizumab, abatacept, rituximab). Updacitinib has a PDUFA date of 8/19/2019 and has been designated a Breakthrough Therapy and an Orphan Drug. 
2. Onasemnogene abeparvovec (Novartis/AveXis’ Zolgensma) is a single injection gene therapy to replace survival motor neuron (SMN) protein, which is the genetic defect causing spinal muscular atrophy. Onasemnogene abeparvovec will compete with nusinersen (Spinraza, Biogen) an antisense oligonucleotide that increases functional SMN protein production by modifying translation from the SMN2 gene to SMN protein. Onasemnogene abeparvovec has a PDUFA date of 5/3/2019. In addition to Orphan Drug status, onasemnogene abeparvovec has also been designated a Breakthrough Therapy and has Fast Track status. In Europe the drug has Orphan Drug and PRIME status. 
3. Risankizumab (Skyrizi, Boehringer Ingelheim and AbbVie) is an interleukin-23 inhibitor being developed for the treatment of Psoriasis and Crohn’s disease. The drug is an Orphan Drug and has a PDUFA date of 4/25/2019. Risankizumab will compete with other IL-23-targeting drugs (ustekinumab, tildrakizumab, guselkumab, IL-17 blockers (secukinumab) and TNF-blockers.
4. Aimmune’s AR101 is an oral desensitization immunotherapy being developed for peanut allergy. AR101 has been granted Breakthrough Therapy and Fast Track status by the FDA. Because the FDA feels that AR101 is not a drug, but an allergenic extract, the product would not be reviewed under the PDUFA process which would provide a priority review in 6 months or a regular review in 10 months. Therefore, the FDA has said a 12-month review would apply, which would place the review in January 2020. Immune is discussing the prospect of AR101 being declared a drug and Clarivate has forecast a decision in November 2019 (10-month PDUFA review timeline). If AR101 is approved at the end of 2019 or early 2020, it will enter the market with no commercial competition. The closest challenger is the transdermal Visken Peanut patch from DBV Technologies. DBV initially submitted a BLA in 2018 but pulled the BLA to provide more data on manufacturing and quality control. ​

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