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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Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease

Shots:

  • The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition
  • The study showed greater ORR @24wks. i.e 1EPs (49.7% vs 25.6%); @24wks. mFFS (not reached vs 5.7 mos.); greater symptom improvement per mLSS (24.2% vs 1.0%); no new safety signals were observed while AEs were consistent
  • The PR shortens the review period from 10 to 6mos. The anticipated PDUFA date is Jun 22, 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Business Journals

The post Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease first appeared on PharmaShots.

BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

Shots:

  • The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies
  • Additionally, safety data from 779 patients in 6 trials of Brukinsa were included in the submission with the anticipated PDUFA date as Oct 18, 2021. Brukinsa is also under regulatory review in the EU, Canada, Australia, China, Taiwan, and South Korea
  • Currently, 20+ marketing applications of Brukinsa have been submitted covering 45 countries globally including the US, EU & China

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Switzerland Global Enterprise

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Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Shots:

  • The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR)
  • CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). Result: The 1EPs is (PFS) based on the blinded independent central review (BICR) and 2EPs involve PFS based on OS, ORR, intracranial objective response, and safety
  • Lorbrena is a tyrosine kinase inhibitor (TKI) especially developed to inhibit tumor mutations and to penetrate the blood-brain barrier

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Michigan Health Lab

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Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test
  • Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no new safety signals identified
  • Xofluza inhibits the cap-dependent endonuclease in the PA protein and is a single-dose oral treatment for influenza which is different from all other currently available antiviral treatments

Click here ­to­ read full press release/ article | Ref: Shionogi | Image: Businesswire

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Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Shots:

  • The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC
  • The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or PBO maintenance therapy in 327 patients in a ratio (1:1). The study demonstrated improvement in PFS with no new safety signals
  • Additionally, the therapy in combination with CT has met its 1EPs in ORIENT-11 study in 1L non-squamous NSCLC patients. Today’s acceptance marks the second sNDA of Tyvyt for 1L NSCLC indication

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots