‘FDA likely to OK 11 blockbuster candidates in August’

Kim Yun-mi  Published 2019.07.29  16:55  Updated 2019.07.29 16:55


The U.S. Food and Drug Administration (FDA) will likely approve 11 innovative medicines in August, and the list includes a strong blockbuster candidate upadacitinib, an oral Janus kinase (JAK) inhibitor, a market research firm said.

According to EvaluatePharma’s forecast, the FDA is expected to make decisions on 45 new drugs in 2019.

Eighteen of them have already obtained the nod in the first half.

The other 27 new drugs are awaiting FDA’s decisions in the second half-year, and 11 of them will see the results next month, EvaluatePharma said.

Among the investigational drugs with imminent FDA decisions, AbbVie’s oral JAK inhibitor upadacitinib is drawing attention the most. AbbVie is studying upadacitinib to treat moderate to severe rheumatoid arthritis and other immune-mediated diseases.

The company is testing the agent not only for rheumatoid arthritis but for psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis, ankylosing spondylitis, and giant cell arteritis in phase-3 trials.

Analysts predict that upadacitinib will become an innovative drug to replace Humira (ingredient: adalimumab).

AbbVie’s Humira earns over half of the company’s revenue, but its patent in the U.S. expires in 2023. The drugmaker is desperate to develop a follow-up blockbuster to counter the attacks from biosimilar drugs.

Major market research firms and medical journals picked upadacitinib as one of the dark horses this year, projecting that the drug is expected to sell about $2.5 billion (2.96 trillion won) globally by 2024.

Pharmaceutical news outlet FiercePharma also placed upadacitinib at No. 2 in the top 10 new medicines that are expected to sell the most in 2024.

Another significant new drug anticipating an FDA green light is Roche’s personalized anticancer drug entrectinib (brand name: Rozlytrek).

Roche hopes to obtain the nod for entrectinib’s indication for neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumor and ROS1 fusion-positive non-small cell lung cancer.

In June, Japan’s Ministry of Health, Labor and Welfare approved entrectinib for the treatment of NTRK fusion-positive solid tumor. As the drug targets genetic NTRK gene fusions, Japan approved NTRK fusion-positive, advanced or recurrent 10 solid tumors that appear in breast, colorectal, neuroendocrine, lung, pancreatic, thyroid, and salivary gland.

Roche expects entrectinib will potentially produce $500 million to $1 billion in profits.

Daiichi Sankyo has been working to win approval for two new drugs in August but is likely to get only one.

The FDA Oncologic Drugs Advisory Committee in May voted in favor of the company’s tenosynovial giant cell tumor treatment pexidartinib. However, the company received a complete response letter from the FDA for quizartinib for the treatment of acute myeloid leukemia, meaning it failed to obtain the nod.

Other new drugs anticipating FDA decisions in August include Kala Pharmaceutical’s dry eye treatment KPI-121, Sarepta Therapeutics’ muscular dystrophy drug Golodirsen, Nektar Therapeutics’ opioid-using pain drug NKTR-181, and Nabriva Therapeutics’ antibiotic Lefamulin for pneumonia.

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