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5 Biggest New Drug Approvals Potentially on the Way in 2019

Keith Speights, The Motley Fool

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.

FDA approved stamp

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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.

4. Luspatercept

Luspatercept landed at No. 4 on EvaluatePharma's list. Acceleron originally developed the drug, but Celgene partnered with the small biotech in 2011 and is advancing luspatercept through the regulatory approval process. 

Celgene filed for FDA approval of luspatercept in treating beta-thalassemia and in treating myelodysplastic syndromes (MDS)-associated anemia. The FDA should make its decision on the beta-thalassemia indication by Dec. 4, 2019, with a decision on the MDS indication expected by April 4, 2020. EvaluatePharma projects that the drug will generate annual sales of close to $1.1 billion by 2024.

5. Tenapanor

Small biotech Ardelyx should be only a few weeks away from some big news. The FDA is scheduled to announce an approval decision for tenapanor in treating irritable bowel syndrome with constipation (IBS-C) by Sept. 12, 2019. 

EvaluatePharma expects that the drug could pull in nearly $700 million annually by 2024 if it's approved. Ardelyx hopes that the IBS-C is only the first of two approved indications for tenapanor. The company is also evaluating the drug in a phase 3 clinical study for treating hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.

Big impacts

FDA approvals for lumateperone and tenapanor would definitely have huge impacts for Intra-Cellular Therapies and Ardelyx. Neither company has an approved product on the market yet. 

Bristol-Myers Squibb is in the process of acquiring Celgene. The FDA approvals for luspatercept are more important to this deal now that U.S. regulators are requiring BMS to sell Celgene's blockbuster psoriasis and psoriatic arthritis drug Otezla.

Novartis is embroiled in a scandal over its use of falsified preclinical data in its FDA application package for gene therapy Zolgensma. Approval for potential massive blockbuster brolucizumab could help reassure investors about the big pharma stock.

AbbVie faces declining sales for Humira, currently the top-selling drug in the world. FDA approval for upadacitinib is an enormously important component of the company's strategy to offset its issues with Humira.

The bottom line is that these big new drug approvals potentially on the way in the rest of 2019 (or in the case of upadacitinib, already approved) could be bigger to the companies involved than meets the eye.


Keith Speights owns shares of AbbVie and Celgene. The Motley Fool owns shares of and recommends Celgene. The Motley Fool has a disclosure policy.

This article was originally published on Fool.com