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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Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

Shots:

  • The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period
  • The study met 1EPs i.e. 80% of patients achieved INCAT response with 1.0 g/kg dose. Dose-dependent responses demonstrate 1.0 g/kg and 2.0 g/kg dose arms in grip strength, I-RODS, and MRC sum scores and were well tolerated
  • Panzyga is the only IVIg with two FDA-approved maintenance dosing options for CIDP and has received the US FDA’s approval in 2018 for PI and cITP in adults

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

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ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment of Adults with Multidrug-Resistant HIV

Shots:

  • The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3)
  • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a 1st in class HIV-1 attachment inhibitor

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma

Shots:

  • The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings
  • Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best response or PR, mDOR (1.4mos.); patients achieving CR, 65% had remission lasting at least 6mos. and 62% had remission lasting at least 9mos.
  • Breyanzi is a CD19-directed CAR T cell therapy with defined composition and 4-1BB costimulatory domain. Additionally, the US FDA has granted ODD, RMAT and BT Designation to the therapy

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

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Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Shots:

  • Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes
  • The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning
  • The technology sustains performance for ~14days, providing trends, insights & actionable data on a reader or with the FreeStyle LibreLink mobile app. FreeStyle Libre 2 will be available for people with diabetes aged ≥4yrs. in Canada in the coming months

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

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Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Shots:

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Source1, Source2 ­to­ read full press release/ article | Ref: Genentech & Novartis | Image: Dr. Thomas Chacko

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Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

Shots:

  • The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020
  • In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was like the well-established safety profile of Jardiance. In Mar’2020, the US FDA granted FT designation to the therapy for CKD based on its ongoing EMPA-KIDNEY study with its expected results in 2022
  • In 2019, the US FDA granted FT designation to Jardiance for the reduction of the risk of CV death and hospitalization for heart failure in people with HF based on its EMPEROR program, which consists of two P-III studies EMPEROR-Reduced & EMPEROR-Preserved

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Dialysis Patient Citizens Education Center

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GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults

  • The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
  • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
  • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

Click here ­to­ read full press release/ article | Ref: MC2 Therapeutics | Image: MC2 Therapeutics

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Shots:

  • The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs.
  • The two studies demonstrated improvements in motor function in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. The filing of MAA to EMA for the therapy is imminent while the therapy has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan
  • Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics and is the only therapy for SMA that can be taken at home. It will be available in the US within 2wks. for direct delivery to patients’ homes through Accredo Health Group

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