5 Biggest New Drug Approvals Potentially on the Way in 2019

AbbVie (NYSE:ABBV) and Novartis (NYSE:NVS) scored key drug approvals by the U.S. Food and Drug Administration (FDA) earlier this year. Each of the two companies landed products in market researcher EvaluatePharma’s top-five list of the biggest new drugs approved so far in 2019.

But what about important FDA approvals that could be on the way in the remaining months of the year? EvaluatePharma also ranked the five biggest potential new drug approvals on the way in 2019. AbbVie and Novartis made this list, too. So did big biotech…

Celgene (NASDAQ:CELG) and three smaller drugmakers, Acceleron Pharma (NASDAQ:XLRN)Ardelyx (NASDAQ:ARDX) and Intra-Cellular Therapies (NASDAQ:ITCI). Here’s which of these companies’ pipeline candidates ranked on EvaluatePharma’s list.

1. Upadacitinib

EvaluatePharma ranked AbbVie’s Skyrizi as the No. 1 new drug approved so far this year. Another immunology drug from AbbVie, upadacitinib, took the top spot on the market researcher’s list of the biggest new drug approvals on the way.

Actually, this top drug on EvaluatePharma’s list isn’t on the way to FDA approval anymore. On Friday, the FDA gave a thumbs-up to upadacitinib, which AbbVie plans to sell under the brand name Rinvoq. EvaluatePharma projects that the drug will generate annual sales of more than $2.5 billion by 2024. AbbVie, however, thinks that upadacitinib could ultimately reach peak annual sales of $6.5 billion.

2. Brolucizumab

Novartis landed drugs in the No. 3 and No. 4 positions on EvaluatePharma’s ranking of new drugs approved so far in 2019. The Swiss pharmaceutical company’s wet age-related macular degeneration (AMD) drug brolucizumab ranked No. 2 among the top potential new drug approvals on the way this year, according to EvaluatePharma.

The FDA accepted Novartis’ filing for brolucizumab on April 15. Since the company used a priority review voucher, the review process should be completed within six months, with an FDA decision on the way by mid-October. EvaluatePharma estimates that the wet AMD drug, assuming it’s approved, could make nearly $1.2 billion annually by 2024. GlobalData analysts project that brolucizumab could reach peak annual sales of between $4.1 billion and $7 billion.

3. Lumateperone

Intra-Cellular Therapies could be headed for a game-changing year if its schizophrenia drug lumateperone wins FDA approval. EvaluatePharma views lumateperone as the third-biggest potential new drug approval ahead in the back half of 2019.

However, this one is really iffy. The FDA canceled an advisory committee meeting in July and pushed back the PDUFA date (the deadline for completing its review of a drug) from Sept. 27, 2019, to Dec. 27, 2019. The agency also requested additional data related to toxicity findings in animals in preclinical studies. If lumateperone goes on to win approval, though, EvaluatePharma expects the drug will rack up annual sales of more than $1.1 billion by 2024…

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