NEWS

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Shots: The US FDA has approved the company’s Vafseo (vadadustat) tablets as a treatment of anemia associated with chronic kidney disease (CKD) in adults on dialysis for at least 3mos. The company, in collaboration with CSL Vifor, will commercialize Vafseo across the US The approval was based on the safety and efficacy results from INNO2VATE…

March 27, 2024

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Shots: The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along…

March 26, 2024

Norgine’s NPJ5008 (Dantrolene sodium hemiheptahydrate) Receives CHMP’s Positive Opinion for the Treatment of Malignant Hyperthermia

Shots: Norgine received a positive CHMP opinion for NPJ5008 (Dantrolene sodium hemiheptahydrate) for the treatment of Malignant Hyperthermia With NPJ5008, dantrolene is prepared and administered quickly using novel formulation vs. Dantrolene IV (dantrolene sodium). NPJ5008 (IV) contains 120 mg of dantrolene in each vial and is reconstituted in 20 mL of water For its final…

March 26, 2024

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…

March 22, 2024

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…

March 22, 2024

Outlook Therapeutics’ Lytena Gains the CHMP’s Positive Opinion for the Treatment of Wet AMD

Shots: Outlook’s Lytenava has received CHMP’s positive opinion to treat Wet AMD. If approved Lytenava expected to gain 10 yrs of market exclusivity in EU The opinion was supported by 3 wet AMD clinical programs (NORSE ONE, NORSE TWO & NORSE THREE) assessing ONS-5010 along with retrospective bibliographic literature Lytenava, an ophthalmic formulation of bevacizumab,…

March 22, 2024

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Shots: The recommendation was supported by the P-III studies (BE HEARD I and BE HEARD II) assessing the safety and efficacy of Bimzelx 1014 patients with PsA evaluating bimekizumab vs. PBO at week 16 Both trials met their 1EPs & 2EPs measured by HiSCR50 and HiSCR75 respectively at wk. 16. Clinical responses were sustained up…

March 22, 2024

Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The opinion was based on the P-III (APPLY-PNH) & (APPOINT-PNH) trials of Fabhalta (200mg, oral, BID) in PNH patients with residual anemia who switched from Anti-C5 and complement inhibitor naïve (incl. anti-C5 therapies) respectively for 24wks. In the APPLY-PNH study, 82.3% vs 2.0% had a ≥2 g/dL increase in Hb levels without transfusions while…

March 22, 2024

Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections

Shots: Pfizer’s Emblaveo has received a positive CHMP opinion for the treatment of patients with cIAI, HAP (incl. VAP), and cUTI (incl. Pyelonephritis). The MAA was supported by results from the P-III study comprising the REVISIT and ASSEMBLE studies evaluating the efficacy, safety, and tolerability of Emblaveo in treating serious bacterial infections due to Gram-negative…

March 22, 2024

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

Shots: Novo Nordisk’s Awiqli (QW basal insulin icodec) has received CHMP’s positive opinion and recommending it for the final approval which is anticipated in next ~67days/ ~2mos The opinion was supported by the six P-IIIa (ONWARDS) study assessing the safety & efficacy of Awiqli in type 1 & type 2 diabetes adults (n= >4,000) incl.…

March 21, 2024

NEWS

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Norgine’s NPJ5008 (Dantrolene sodium hemiheptahydrate) Receives CHMP’s Positive Opinion for the Treatment of Malignant Hyperthermia

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

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

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