Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots:

  • The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
  • The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score
  • Otezla is a selective PDE4 inhibitor, approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy, for active PsA, and for with oral ulcers associated with Behçet’s Disease

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Conejo Valley Guide

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Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Shots:

  • The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of abivertinib now cleared to proceed in both Brazil and the US
  • The dose to be tested is the same as in the US P-II trial but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of 7 days (versus 14 days for more advanced patients in the US)
  • Both the studies are complementary and address both dose duration and disease stage

    Click here to­ read the full press release/ article | Ref: Sorrento Image: Newsmax

The post Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil first appeared on PharmaShots.

Lupin and SunPharma Launch Generic Favipiravir to Treat Mild to Moderate COVID-19 in India

Shots:

  • Lupin has launched favipiravir in India under the brand name ‘Covihalt’ for the treatment of mild to moderate COVID-19
  • Covihalt will be available as 200mg tablets in the form of a strip of 10 tablets, priced at $0.65 (₹49/tablet) and has received DCGI authorization for emergency use
  • Additionally, SunPharma has launched antiviral drug favipiravir under the brand name ‘FluGuard’ to treat mild to moderate cases of COVID-19, at ₹35/tablet in India

Lupin, SunPharma ­to­ read full press release/ article  | Image: StraitTimes




Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Shots:

  • The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19
  • Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of the virus. 2EPs include 40% faster achievement of clinical cure, patients receiving clinical cure @day4 (69.8% vs 44.9%) median time to first-time use of oxygen in clinically deteriorated (5days vs 2days)
  • on June 20, 2020, FabiFlu has received DCGI’s approval, making it the first oral approved medication in India for the treatment of mild to moderate COVID-19. Glenmark has initiated PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 patients

Click here to read full press release/ article | Ref: Glenmark | Image: IndiaTVNews

Related News: Glenmark Launches FabiFlu (favipiravir) as the First Oral Medication to Treat Mild to Moderate COVID-19 in India