Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Shots:

  • The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas
  • The BLA is based on clinical trials that assess TicoVac across two age groups (aged 1-15yrs. and 16-65yrs.). The studies showed pooled seropositivity rates 99-100% and 94-99% following three doses respectively
  • The real-world studies demonstrated that the vaccine is 96-99% effective in people who have received at least 2 doses of the vaccine and 2-3 doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory

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

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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

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Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

Shots:

  • The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged ≥12yrs. in a ratio (2:2:1) diagnosed with AD for at least 2yrs. and who were candidates for topical therapy
  • Patients who completed an assessment @8wks. were offered participation in the 44wks. long-term safety treatment extension period with ruxolitinib cream (0.75%/1.5%, bid)
  • The company submitted PRV along with NDA to the FDA which shortens the review period by 4mos. The anticipated PFUFA date is Jun 21, 2021

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

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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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Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Shots:

  • The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021
  • The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent glioblastoma, mRCC in combination with interferon alfa and persistent, recurrent or metastatic cervical cancer
  • The FDA’s acceptance brings Bio-Thera closer to providing cancer patients in the US with a high-quality, low-cost treatment option

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

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Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots:

  • The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic SCAC who have progressed on or are intolerant of standard platinum-based CT
  • The study demonstrates 14% ORR for retifanlimab monotherapy as determined by ICR using RECIST v1.1 and mDOR of 9.5mos
  • Retifanlimab has received FDA’s ODD for the treatment of anal cancer along with PR which shortens the review period by 4mos vs Standard Review. The PDUFA target action date is Jul 25, 2020

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Technical.ly

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Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Shots:

  • The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021
  • The BLA filing marks the milestone on the path to commercialization of narsoplimab
  • Narsoplimab is an investigational mAb targeting MASP-2 has received the US FDA’s BTD and ODD to the FDA for each of HSCT-TMA and IgA nephropathy

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

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Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Shots:

  • The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
  • The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
  • In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

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

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Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Shots:

  • The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD
  • The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 cm/year); the treatment difference in height velocity was 0.33 cm/yr
  • The anticipated PDUFA date is Oct 2021 and is approved, the therapy is served as a once-weekly treatment option

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

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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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Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Shots:

  • EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI
  • In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, EU, Japan, and Australia
  • Ranibizumab is an anti-VEGF therapy for retinal vascular disorders, which is a leading cause of blindness in the US

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

The post Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders first appeared on PharmaShots.

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Shots:

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

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

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Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Shots:

  • The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application
  • Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in ~70 infants and young children with achondroplasia, aged 0-<60mos., for 52wks.
  • Vosoritide (qd) is an investigational injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received the US FDA’s & EMA’s ODD for the same

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioMarin Careers

The post Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia first appeared on PharmaShots.

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Shots:

  • The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021
  • G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter clinical trials while the NDA for the therapy is under regulatory review, pursuant to FDA’s EAP
  • Trilaciclib is an investigational therapy designed to preserve bone marrow and immune system function during CT and improve patient outcomes and has received the US FDA’s BT designation in 2019

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

PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Shots:

  • The MAA submission is based on dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies evaluating the efficacy and safety of Evrysdi (risdiplam) in symptomatic infants with type 1 SMA aged 2-7mos. and in people with types 2/3 SMA aged 2-25 yrs/ respectively
  • The submission also includes data from JEWELFISH study evaluating patients with all types of SMA aged 1-60yrs. prior treated with other SMA therapies. Exploratory efficacy analysis from SUNFISH Part 1 showed Evrysdi improved motor function @24mos. of treatment, Part 2 of the FIREFISH study met its 1EPs of infants sitting without support for 5sec by month 12, as assessed by BSID-III, Part 2 of the SUNFISH trial demonstrated that change from baseline in MFM-32 score was greater at 12mos.
  • Roche will grant $15M as milestones to PTC following MAA acceptance. Evrysdi is an SMN2-directed RNA splicing modifier designed to treat SMA caused by mutations in chromosome 5q leading to SMN protein deficiency

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

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved, Xolair’s prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

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

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Shots:

  • The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
  • The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
  • Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

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

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