Insights+: The US FDA New Drug Approvals in March 2021
The US FDA has approved 7 NDAs in Mar 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 19 novel products in 2021.
Additionally, last year in 2020, the US FDA has approved 121 novel products. PharmaShots has compiled a list of a total of 7 new drugs approved by the US FDA in Mar 2021
Published: Mar 03, 2021 | Tags: Corium, Azstarys (serdexmethylphenidate and dexmethylphenidate), Capsule, Receives, US, FDA, Approval, ADHD, Patients, Age 6 Years and Older
- The approval is based on a P-III study that involves assessing Azstarys (qd) vs PBO in 150 children aged 6-12yrs. with ADHD
- The study showed improvement in 1EPs i.e. ADHD symptoms, reduction in SKAMP-C score (-5.4points)
- Azstarys is the first and only product containing a d-MPH oral prodrug for the treatment of ADHD and will be available as 3 dosage strength- 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg with the anticipated launch in summer 2021
Published: Mar 10, 2021 | Tags: AVEO Oncology, Fotivda (tivozanib), Receives, US, FDA, Approval, Treatment, R/R, Advanced Renal Cell Carcinoma
- The approval is based on a P-III TIVO-3 study that involves assessing Fotivda (1.34 mg/qd, with or without food for 21days followed by 7days off treatment) vs sorafenib in 350 patients in a ratio (1:1) with r/r advanced RCC following two or more prior systemic therapies.
- The application is also supported by three additional trials in RCC and includes safety data from 1,000+ trial subjects. The P-III TIVO-3 study results: mPFS (5.6 vs 3.9mos.), m-OS (16.4 vs 19.2mos.), ORR (18% vs 8%).
- Fotivda (tivozanib, qd, PO) is a VEGF tyrosine kinase inhibitor and is available to patients in the US by Mar 31, 2021
Published: Mar 15, 2021 | Tags: Melinta, Kimyrsa, (oritavancin), Receives, US, FDA, Approval, Treatment, Acute Bacterial Skin and Skin Structure Infections
- The approval is based on P-III SOLO trial involves assessing the safety, efficacy, and PK of Kimyrsa (qd, 1200 mg, IV dose, over 1 hour) vs vancomycin (1gm or 15 mg/kg, bid, over 3 hours) in 1,987 adults with ABSSSI
- The 1EP and 2EP of the trial demonstrated that shorter infusion time and lower infusion volume of Kimyrsa is as effective as 7-to-10 days twice-daily vancomycin
- Kimyrsa is a long-acting lipoglycopeptide antibiotic with rapid bactericidal activity for the treatment of adult patients with ABSSI caused by designated Gram-positive microorganisms, including MRSA and is expected to be available in the US in 2021
Published: Mar 22, 2021 | Tags: Janssen, Ponvory (ponesimod), Receives, US, FDA, Approval, Treatment, Relapsing, Multiple Sclerosis
- The approval is based on the P-III head-to-head OPTIMUM trial involves assessing Ponvory (20 mg) vs Teriflunomide (14 mg) in adults with relapsing MS and follows >10 yrs of cumulative data demonstrating its efficacy and safety
- The results demonstrated superior efficacy in reducing annual relapses by 30.5%, no confirmed relapses (30.5% vs 61%), reducing the number of new GdE T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, confirmed disability progression
- Ponvory (ponesimod) is a selective S1P1 modulator to treat adults with relapsing MS and is the 1st and only FDA-approved oral disease modifying therapy studied against an established oral comparator
Published: Mar 24, 2021 | Tags: Zealand, Zegalogue (dasiglucagon), Receives, US, FDA, Approval, Treatment, Severe Hypoglycemia
- The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D
- The study met its 1EPs showed an increase in blood glucose of =20 mg/dL within 45 minutes, the median time to blood glucose recovery (10min vs 30-45min), following injection of 0.6 mg/0.6 ml of therapy, 99% of patients recovered within 15 minutes in adults
- Zegalogue will be available in both an auto-injector and a prefilled syringe to treat hypoglycemia in patients with diabetes aged =6yrs.
The US FDA Approves New Indication and Formulation for Astellas Myrbetriq
Published: Mar 26, 2021 | Tags: Astellas, Myrbetriq (mirabegron), New Indication, New Product Formulation, Receives, US, FDA, Approval, Treatment, Neurogenic Detrusor Overactivity, Children
- The FDA has approved Myrbetriq (ER tablets) for NDO in children aged =3yrs. who weigh =35kg and Myrbetriq Granules (ER oral suspension) for NDO in pe children aged 3yrs. The FDA has granted pediatric exclusivity for Myrbetriq, resulting in an additional 6mos. period of market exclusivity
- The approval for the NDO indication is based on P-III study involves assessing Myrbetriq in children & adolescents aged 3-<18yrs with NDO using clean intermittent catheterization
- Myrbetriq tablets are available in the US while Myrbetriq granules are developed for use in younger children, or children with NDO who have difficulty in swallowing tablets and will be available in the US at the end of 2021
Published: Mar 31, 2021 | Tags: Althera, Roszet, Receives, US, FDA, Approval, Treatment, Elevated, Low-Density Lipoprotein Cholesterol
- The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia
- The result showed a reduction of LDL cholesterol by 72% with 40mg/10mg dose and 64% with 10 mg/10mg dose. The level of LDL-reduction indicates from both the statin component i.e rosuvastatin reduces LDL cholesterol by 63% on the highest dose and 52% on 10 mg dose, and the ezetimibe component showed a reduction by 25% when added to statins
- Roszet (PO,qd) is available as combination tablet of 5mg/10mg, 10mg/10mg, 20mg/10mg and 40mg/10mg
Related Post: The US FDA New Drug Approvals in February 2021
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