[{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amgen Announces Positive Top-Line Results From Otezla\u00ae (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Global Coalition for Adaptive Research","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Global Coalition for Adaptive Research, Amgen, and Eisai Announce First Patient Enrolled in International COVID-19 Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Unichem Laboratories Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Unichem Labs Gets USFDA Approval for Apremilast Tablets","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amgen Submits Supplemental New Drug Application for Otezla\u00ae (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase 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Level","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amgen Announces New Otezla (Apremilast) Data at AAD Congress 2022","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amgen to Present New, Positive Clinical and Real-World Data Across Inflammation Portfolio At EADV 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(apremilast)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Apremilast
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP), indicated for the treatment of plaque psoriasis in adults.
16-week data demonstrated clinically meaningful and statistically significant improvement in genital psoriasis, with twice many patients achieving primary endpoint of clear (0) or almost clear (1) sPGA-G scale receiving Otezla (apremilast) when compared with placebo.
Presentations will cover a range of clinical data for Otezla® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis.
New data further reinforces clinical benefit of Otezla (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 in mild to moderate plaque psoriasis and in patients with palmoplantar pustulosis.
The adverse events observed in the trial were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea, headache, nausea and nasopharyngitis.
Zydus Pharmaceuticals (USA) Inc. has received final approval from the US Food and Drug Administration (FDA) to market apremilast tablets in the strengths of 10 mg, 20 mg, 30 mg tablets are indicated for treatment of adult patients with plaque psoriasis.
Otezla® (apremilast) has potential to be first and only approved oral therapy for the mild-to-moderate patient population. Acceptance based on data from Phase 3 ADVANCE Study, demonstrating clinically meaningful improvements through week 32.
The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.
The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.
Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Amgen’s Otezla® (apremilast) Tablets, 10 mg, 20 mg, and 30 mg.
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