Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Shots: The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks. The study depicted a greater reduction…

ByDipanshu DixitMarch 22, 2024

NEWS

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Shots: The US FDA has granted approval to Italfarmaco’s Duvyzat (givinostat), histone deacetylase (HDAC) inhibitor, to treat Duchenne muscular dystrophy (DMD) patients (6yrs. or above) The approval was supported by the P-III (EPIDYS) study assessing the safety & efficacy of Duvyzat (BID) vs PBO in DMD ambulant male patients (n=179, 6yrs. or above) The trial…

ByDipanshu DixitMarch 22, 2024

NEWS

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Shots: The US FDA has approved Tryvio (12.5mg, oral, QD, with/without food) in addition with antihypertensive drugs to treat hypertensive adults not controlled on other drugs The P-III (PRECISION) trial assessed the efficacy of Tryvio for hypertensive adults with SBP ≥140 mmHg receiving at least 3 antihypertensive therapies with the 1EP as change in SiSBP…

ByDipanshu DixitMarch 20, 2024

NEWS

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Shots: The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759) The results after 52wks. showed improved NASH resolution (incl. a…

ByDipanshu DixitMarch 14, 2024

NEWS

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24 The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs…

ByDipanshu DixitMarch 14, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of February 2024 The US FDA approved a total of 7 drugs including 6 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Takeda’s Eohilia (budesonide oral suspension) for treating eosinophilic…

BySenior EditorMarch 13, 2024

NEWS

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Shots: Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

ByDipanshu DixitMarch 10, 2024

NEWS

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

Shots: Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk…

ByDipanshu DixitMarch 5, 2024

NEWS

Formosa Pharmaceuticals Receives the US FDA’s Approval for Clobetasol Propionate to Treat Post-Operative Inflammation and Pain Following Ocular Surgery

Shots: The US FDA has approved Formosa’s clobetasol propionate ophthalmic suspension 0.05% (APP13007) to treat post-operative inflammation & pain following ocular surgery Sosei Heptares will receive a payment of $2.5M from Formosa on achieving the milestone as per the agreement signed b/w them APP13007 was initially developed by Activus Pharma (subsidiary of Sosei) using its…

ByDipanshu DixitMarch 4, 2024

NEWS

The US FDA Approves Hugel’s Letybo for the Treatment of Glabellar Lines

Shots: The US FDA has granted approval to the company’s Letybo for 50 and 100 units to treat moderate-to-severe glabellar lines in adults The approval was based on the data from three P-III completed studies that recruited more than 1,000 participants across the US and the EU The data from the clinical studies showed the…

ByDipanshu DixitFebruary 28, 2024

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Insights+: The US FDA New Drug Approvals in February 2024

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

Formosa Pharmaceuticals Receives the US FDA’s Approval for Clobetasol Propionate to Treat Post-Operative Inflammation and Pain Following Ocular Surgery

The US FDA Approves Hugel’s Letybo for the Treatment of Glabellar Lines

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