FDA Action Alert: Karyopharm, Merck and Celgene

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The month of July is a slow one for the U.S. Food and Drug Administration (FDA), at least in terms of scheduled approval dates. Here’s a look at the three PDUFA dates the agency has on its calendar for the month.

Karyopharm Therapeutics, based in Newton, Massachusetts, has a target action date of July 6 for its New Drug Application (NDA) for selinexor. It previously had a PDUFA date of April 6, but the date was extended by three months.

Selinexor is being considered under Priority Review in combination with dexamethasone for patients with relapsed refractory multiple myeloma who have received at least three previous therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent, and one anti-CD38 monoclonal antibody.

On February 26, the FDA’s Oncologic Drugs Advisory Committee met to vote on recommending the selinexor NDA, voting 8 to 5 to recommend the agency wait for the company’s randomized, open-label, Phase III BOSTON trial that compared selinexor in patients with relapsed or refractory multiple myeloma. After the meeting of the adcom, Karyopharm submitted more clinical data as an amendment to the NDA, which was the reason for extending the PDUFA date.

Merck & Co. has a target action date of July 16 for its NDA for the combination of relebactam. Relebactam is the company’s beta-lactamase inhibitor with imipenem/cilastatin (IMI/REL). It was developed for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by specific susceptible Gram-negative bacteria.

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Relebactam is an intravenous class A and C beta-lactamase inhibitor. The FDA designated the combination of relebactam with imipenem/cilastatin for IV use as a Qualified Infectious Disease Product (QIDP) with Fast Track status for cUTI, cIAI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).

The NDA is built on data from the Phase III RESTORE-IMI 1 clinical trial. Data was presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting held in Madrid, Spain in April 2018.

Celgene has a target action date of July 21 for its supplemental NDA (sNDA) of Otezla (apremilast) in Behcet’s disease. On February 17, 2018, Celgene announced data from its Phase III RELIEF trial of Otezla in patients with active Behcet’s disease with oral ulcers. The company presented the data at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The data showed statistically significant decreases in oral ulcers with the drug compared to placebo.

Behcet’s disease is a rare, chronic, multi-system inflammatory syndrome. They are the most common manifestation of the disease and can be disabling. The study mostly looked at the effect of the drug on recurring oral ulcers in patients with active oral ulcers who had previously been treated with at least one topical or systemic drug.

On June 24, Bristol-Myers Squibb, as part of its acquisition of Celgene, indicated it plans to divest the company of Otezla, which is approved for psoriasis and psoriatic arthritis. That divestiture is in response to concerns by the U.S. Federal Trade Commission (FTC) over the merger, which is expected to close by the end of this year or in early 2020.

Bristol-Myers Squibb has a rival TYK2 psoriasis drug in Phase III trials called BMS-986165. Otezla brought in $1.6 billion in 2018, up from $1.28 billion in 2017.

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