9 Massachusetts Biotechs Facing Major FDA Decisions This Year

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March 3, 2017
By Alex Keown, BioSpace.com Breaking News Staff

BOSTON – Regulatory approval of a new drug can inject new life into a company and instill a massive amount of confidence in investors. There are nine Boston-area biotech companies awaiting a ruling from the U.S. Food and Drug Administration (FDA) this year.

The Boson Business Journal highlighted each of the drugs awaiting regulatory approval and the target date for the ruling.

1. Sanofi Genzyme

Cambridge-based Sanofi Genzyme is waiting for the FDA to rule on two drugs, dupilumab, a treatment for atopic dermatitis and sarilumab, a treatment for rheumatoid arthritis. The FDA is expected to make a decision on dupilumab on March 29, while sarilumab will be ruled on during the second quarter, the Boson Business Journal said. Phase III data from the two trials of 1,379 patients showed that dupilumab was successful in clearing the rash associated with atopic dermatitis. Phase III data showed sarilumab improved the signs and symptoms of rheumatoid arthritis (RA) patients after 24 weeks of use. Sarilumab is an investigational, human IL-6 receptor antibody designed to inhibit the inflammatory activity in.

2. Radius Health

Waltham, Mass.-based Radius Health is expecting the FDA to rule on Abaloparatide-SC, an investigational synthetic peptide for the treatment of postmenopausal women with osteoporosis on March 30. As previously reported if approved, Abaloparatide-SC is expected to be the first new bone anabolic treatment option in the U.S. since 2002. With osteoporosis being a global issue, some analysts have said the drug has the potential to generate more than $1 billion in sales should it be approved.

3. Ariad Pharmaceuticals

Although recently acquired by Takeda Pharmaceuticals , Ariad is awaiting approval of its lung cancer treatment Brigatinib. The FDA is expected to make its decision on April 29. Brigatinib is being developed for patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) whose disease is resistant to crizotinib.

4. Ironwood Pharmaceuticals

The FDA is expected to rule on Ironwood’s gout therapy, Duzallo, in the second half of 2017.

5. Shire

Lexington, Mass.-based Shire is anticipating a June 20 ruling for its ADHD therapy, SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation.

6. Tesaro

Tesaro , based in Waltham, Mass. is awaiting a June 30 ruling for its ovarian cancer drug Niraparib, an oral, once-daily PARP inhibitor. Tesaro said niraparib increased progression free survival in different cohorts of a 553-patient trial—whether they had the BRCA gene or homologous recombination deficient (HRD) tumors. Trial data showed patients with the BRCA gene had 21 months of progression free survival—15 months longer than the control group. Additionally, patients in the non-germline BRCA mutant cohort showed progression free survival of 9.3 months, compared to 3.9 months for control.

7. Ocular Therapeutics

Based in Bedford, Mass., Ocular Therapeutix is expecting a June 19 decision on its post-eye surgery pain drug, Dextenza. This will be the second time that drug comes before the FDA. In July, the U.S. Food and Drug Administration spurned the company’s post-operative eye pain treatment. In a Complete Response Letter, the FDA raised concerns about deficiencies in the manufacturing process, but did not cite any efficacy issues. After attempting to correct the issues, in August Ocular said it intended to seek approval for the drug.

8. Agios Pharmaceuticals

Cambridge, Mass.-based Agios and its partner Celgene are awaiting an Aug. 30 decision on Enasidenib, a treatment for acute myeloid leukemia. The New Drug Application was accepted by the FDA on March 1. Enasidenib is a first-in-class, oral, targeted inhibitor of mutant IDH2.

9. Flexion Therapeutics

Based in Burlington, Mass., Flexion Therapeutics anticipates the FDA to make a decision on its osteoarthritis of the knee treatment Zilretta on Oct. 6. The company submitted its NDA in December. Zilretta received Fast Track designation from the FDA.

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