Insights+: The US FDA New Drug Approvals in December 2021
- The US FDA has approved 8 NDAs and 1 BLAs in Dec 2021, leading to treatments for patients and advances in the health care industry. The CDER and CBER approved 50 novel products in 2021
- In the year 2021, the major highlights were oncology drugs in which 12 out of 50 has approved in oncology, such as Cytalux for ovarian cancer lesions, Scemblix for CML, Tivdak for metastatic cervical cancer, Exkivity for advanced or metastatic NSCLC, Rylaze for ALL and lymphoblastic lymphoma, Lumakras for NSCLC, Pylarify for prostate cancer, Zynlonta for r/r large B-cell lymphoma, Jemperli for endometrial cancer, Fotivda for RCC, Pepaxto for r/rMM, Tepmetko for NSCLC
- PharmaShots has compiled a list of a total of 9 new drugs approved by the US FDA in December 2021
Xaciato
Active ingredient: clindamycin phosphate
Disease: Bacterial Vaginosis
Approved: December 07, 2021
Company: Daré Bioscience
The approval was based on the P-III (DARE-BVFREE) study to evaluate the efficacy and safety of Xaciato vs PBO in a ratio (2:1) in 307 patients aged ≥12yrs. with bacterial vaginosis. The therapy is expected to be available in the US in 2022. The results showed that Xaciato was superior to PBO in the ITT population at day 21-30, patients clinically cured (70.5% (86/122) vs 35.6% (21/59) while patients achieved clinical cure (76.0% vs 23.7%) on Day 7-14. The therapy is administered via a user-filled disposable applicator delivering 5g of gel containing 100mg of clindamycin & has received both QIDP & FD designations from the US FDA for the treatment of bacterial vaginosis
Veru’s Entadfi Receives the US FDA’s Approval for the Treatment of Benign Prostatic Hyperplasia
Entadfi
Active ingredient: finasteride and tadalafil
Disease: Benign Prostatic Hyperplasia
Approved: December 13, 2021
Company: Veru Inc.
The US FDA has approved Entadfi for the treatment of the signs and symptoms of urinary tract symptoms caused by a BPH in men with an enlarged prostate for ~26wks. The therapy is expected to be available in early 2022. Entadfi has also been shown to be more effective to treat urinary tract symptoms caused by BPH & has less potential for adverse sexual side effects compared to finasteride monothx. Entadfi combines finasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor) into 1 capsule formulation. Additionally, The therapy will be marketed and distributed by Veru to patient telemedicine and telepharmacy services platform
Tarpeyo
Active ingredient: budesonide
Disease: IgA Nephropathy
Approved: December 15, 2021
Company: Calliditas
The approval is based on part A of the P-III (NeflgArd) study to evaluate Tarpeyo (16mg, qd) vs PBO in patients with primary IgAN. The therapy is expected to be available in the US in Q1’22The trial met its 1EPs i.e., the therapy showed a 34% reduction in proteinuria from baseline over 5% with RASi alone @9mos., treatment effects of UPCR @9mos. were consistent across key subgroup including demographic & baseline disease characteristics. Tarpeyo is an oral, DR formulation of budesonide & is 1st FDA-approved treatment to reduce proteinuria for the same indication. The company launches a patient support program, Tarpeyo Touchpoints to provide access to patients treated with Tarpeyo
Edenbridge’s Dartisla ODT Receives the US FDA’s Approval for the Treatment of Peptic Ulcer
Dartisla ODT
Active ingredient: glycopyrrolate
Disease: Peptic Ulcer
Approved: December 17, 2021
Company: Edenbridge
The US FDA has approved NDA for Dartisla ODT (glycopyrrolate) to treat adults to reduce symptoms of a peptic ulcer as an adjunct for peptic ulcer. The therapy is supplied as 1.7mg glycopyrrolate ODT & is expected to be available in early 2022 as its first branded specialty prescription product. Additionally, patients receiving the 2mg dose of another oral tablet form of glycopyrrolate can be switched to the 1.7mg dose of glycopyrrolate ODT. The therapy is manufactured by Catalent using Zydis ODT delivery technology to produce a freeze-dried tablet that disperses instantly in the mouth without water
Xarelto
Active ingredient: rivaroxaban
Disease: Venous thromboembolism & Thromboprophylaxis
Approved: December 20, 2021
Company: Janssen
The approval is based on 2 P-III studies i.e., (EINSTEIN-Jr) & (UNIVERSE) trial to evaluate rivaroxaban in 500 & 112 children aged birth to ≤18yrs. & ≥2yrs. with previously diagnosed VTE, following 5 days of initial parenteral anticoagulation treatment & CHD who have undergone Fontan procedure. In (EINSTEIN-Jr) trial, the therapy showed a similar low risk of symptomatic recurrent VTE (1.2% vs 3.0% SoC), In (UNIVERSE) trial, 8.3% & 1.6% of patients in Part A & B experienced a thrombotic event over 8.8% with aspirin. The therapy is available as oral suspension & tablet dosage forms for individuals aged ≥18 yrs. & oral suspension formulation is expected to be available in the US in mid-Jan 2022
ViiV Healthcare’s Apretude (cabotegravir) Receives US FDA’s Approval for the Prevention of HIV
Apretude
Active ingredient: cabotegravir
Disease: Prevention of HIV
Approved: December 21, 2021
Company: ViiV Healthcare
The approval is based on the P-IIb/III (HPTN 083/084) trial to evaluate cabotegravir (q8w) vs FTC/TDF (200/300 mg) in 7,700+ patients who were at high risk of sexually acquiring HIV including HIV-negative men who have sex with men, transgender women & cisgender women across 13 countries. The results demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF) in reducing the risk of HIV. In (HPTN 083 & HPTN 084) trial, participants who received cabotegravir experienced a lower incidence of HIV compared to FTC/TDF (69% & 90%). Apretude is expected to be available in early 2022 in the US. The company has initiated the submissions to other regulatory authorities
Leqvio
Active ingredient: inclisiran
Disease: Atherosclerotic Cardiovascular Disease
Approved: December 22, 2021
Company: Novartis
The approval was based on the P-III (ORION-9/10/11) clinical trials to evaluate Leqvio vs PBO in 3,457 patients with ASCVD or HeFH who require additional lowering of LDL-C while receiving an MTD of statin therapy.In the P-III trials, the therapy showed an effective and sustained LDL-C reduction of 52% compared to PBO @17mos. The therapy was well-tolerated with a safety profile. Under a license and collaboration agreement with Alnylam, Novartis got the rights globally to develop, manufacture & commercialize Leqvio. Additionally, Leqvio is the first siRNA therapy to reduce LDL-C with 2 doses/yr., following an initial dose and a dose at 3mos.
LEO Pharma’s Adbry (tralokinumab) Receives US FDA’s Approval for the Treatment of Atopic Dermatitis
Adbry
Active ingredient: tralokinumab
Disease: Atopic Dermatitis
Approved: December 28, 2021
Company: LEO Pharma
The approval is based on the safety & efficacy results from the P-III (ECZTRA 1/2 & 3) trials to evaluate Adbry (300mg, q2w) with/out TCS in ~2,000 adult patients aged ≥18yrs. with AD who were candidates for systemic therapy. The therapy is expected to be available in Feb 2022. Adbry will be available in a 150 mg/mL SC PFS with an initial dose of 600mg followed by (300mg, q2w). Additionally, the company plans to launch the Adbry advocate program to support US patients through treatment with Adbry. The therapy is the 1st FDA approved biologic that specifically binds & inhibits IL-13 cytokine & marks 5th global regulatory approval for tralokinumab in 2021 which is marketed under the brand name Adtralza (ex-US)
Recorlev
Active ingredient: levoketoconazole
Disease: Endogenous Hypercortisolemia in an adult with Cushing’s Syndrome
Approved: December 31, 2021
Company: Xeris Biopharma
The approval is based on the P-III (SONICS) & (LOGICS randomized-withdrawal) studies to evaluate Recorlev vs PBO in 166 patients with endogenous hypercortisolemia with Cushing’s syndrome. The product is expected to launch in Q1’22. Both studies met their 1EPs & 2EPs i.e., reduction & normalization rate of mean UFC without a dose increase & confirmed the efficacy & safety in normalizing & maintaining therapeutic response. Recorlev is a cortisol synthesis inhibitor & has received ODD from the US FDA & EMA for the same indication. The company has launched the Xeris CareConnection program & provide access to patients including financial assistance, one-on-one support & educational resources
Related Post: Insights+: The US FDA New Drug Approvals in November 2021
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
