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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The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry.

The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021.

Additionally, last year in 2020, the US FDA has approved 105 novel products. PharmaShots has compiled a list of a total of 4 new drugs approved by the US FDA in Jan 2021

Bayer and Merck’s Verquvo (vericiguat) Received the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2021 | Tags: Bayer, Merck, Verquvo (vericiguat), Receives, US, FDA, Approval ,Treat, Chronic Heart Failure

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

ViiV’s Cabenuva (cabotegravir and rilpivirine) Received the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published: Jan 22, 2021 | Tags: ViiV, Cabenuva (cabotegravir and rilpivirine), Receives, US, FDA, Approval, First, Only, Complete, Long-Acting Regimen, HIV treatment

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

ViiV’s Vocabria (cabotegravir, tablet formulation) Received the US FDA’s Approval for the Treatment of HIV-1 infection

Published: Jan 22, 2021 | Tags: ViiV, Vocabria (cabotegravir, tablet formulation), Receives, US, FDA, Approval, Treatment, HIV-1 infection

  • The US FDA approved Vocabria (30mg, tablet formulation) in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation
  • Additionally, changes to the Edurant (rilpivirine) tablet label were revised to reflect the oral lead-in recommendations for use with Vocabria
  • The oral therapy is for the patients who will miss planned injection dosing with Cebenuva

Aurinia’s Lupkynis (voclosporin) Received US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Published: Jan 25, 2021 | Tags: Aurinia, Lupkynis (voclosporin), Receives, US, FDS, Approval, Treat Adult, Patients, Active Lupus Nephritis

  • The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
  • The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
  • Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Related Post: The US FDA New Drug Approvals in December 2020

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Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea

Shots:

  • The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb
  • The P-II SADAL study involves assessing ATG-010 in patients with rrDLBCL, including DLBCL arising from FL, who have received at least 2 prior therapies. The studies demonstrated efficacy with a manageable safety profile for ATG-010
  • ATG-010 (Xpovio) is a first-in-class oral SINE and is the first FDA approved drug for use in both MM and DLBCL

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

The post Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea first appeared on PharmaShots.

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Shots:

  • Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21
  • The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic NET & pancreatic NET patients with an acceptable risk/benefit ratio
  • Surufatinib is an oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR. The US FDA has granted FTD to surufatinib for pancreatic and non-pancreatic NET in Apr’2020 and ODD for pancreatic NET in Nov’2019

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

The post Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors first appeared on PharmaShots.

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots:

  • The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
  • The study provided durable anticancer activity with a positive benefit-risk profile
  • The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible

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

The post Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation first appeared on PharmaShots.

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Shots:

  • The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia
  • The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety and efficacy of TAK-721 in adolescent and adult patients (11-55 yrs. of age) with EoE
  • TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide and has earlier received the US FDA’s BT and ODD

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

The post Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis first appeared on PharmaShots.

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.

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Shots:

  • The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3
  • FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with type 2 or 3 SMA
  • Risdiplam (PO) is a therapy designed to increase and sustain SMN protein levels in the CNS & throughout the body. The therapy has received MHLW’s ODD on Mar 27, 2020, and is a subject to PR in Japan

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

The post Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan first appeared on PharmaShots.

Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Shots:  

  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

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

The post Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension first appeared on PharmaShots.

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Shots:

  • The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China
  • In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s PR in Jul’2020
  • Vericiguat (BAY 1021189/ MK-1242) is an sGC-stimulator being developed to treat patients with symptomatic CHF with an ejection fraction less than 45% who have had a previous worsening HF event in combination with available HF therapies

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

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia
  • The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia in the US

Click here ­to­ read full press release/ article | Ref: Biomarin | Image: Fierce Biotech

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

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

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