new drugs approval

18 new drugs approval by FDA till Apr’21

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There is a total of 18 new drugs approval for the year 2021 to date (Jan-Apr).

F.D.A.‘s Centre for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the developmental process. This process may stem from innovation in developing new therapeutics products and biological products. 

About CDER:

CDER: The Center for Drug Evaluation and Research ensures that safe and effective drugs are available for the public in U.S. CDER regulates O.T.C. (over-the-counter) and prescription drugs. The scope includes biological therapeutics and generic medications. Besides, the control mechanism is applicable for products like fluoride toothpaste, dandruff shampoos, antiperspirants, and sunscreens.

Objective: 

  • Protection of public health by ensuring safe availability, promotion, and marketing of medicines. 
  • Ensuring the availability of safe and effective medicines. 
  • Promote the safe use of marketed drugs.
  • Ensure the quality and integrity of marketed drugs and medicines. 

New Drugs Approval/ Novel Drug Approvals 2021

Zynlonta

  • Brand Name: Zynlonta
  • API: loncastuximab tesirine-lpyl
  • Company: A.D.C. Therapeutics 
  • Patent status: New Molecular Entity
  • Approval Date: 4/23/2021
  • Indication: To treat certain types of relapsed or refractory large B-cell lymphoma.

Approval Basis/Description: Approval was based on LOTIS-2. It is an open-label, single-arm trial in 145 adult patients. The adult patients had relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma after at least two prior systemic regimens. Patients received treatment until progressive disease or unacceptable toxicity.

Jemperli

  • Brand Name: Jemperli
  • API: dostarlimab-gxly
  • Company: G.S.K.
  • Patent status: New Molecular Entity
  • Approval Date: 4/22/2021
  • Indication: To treat endometrial cancer.

Approval Basis/Description: agency evaluated efficacy based on cohort A1 in the GARNET Trial, a multicenter, multicohort, open-label trial in patients with advanced solid tumors. The efficacy population consisted of 71 patients with mismatch repair-deficient recurrent or advanced endometrial cancer who progressed on or after a platinum-containing regimen.

Nextstellis

  • Brand Name: Nextstellis
  • API: drospirenone and estetrol tablets
  • Company: Mayne Pharma, Greenville, NC
  • Patent status: New Molecular Entity
  • Approval Date: 4/15/2021
  • Indication: To prevent pregnancy.

Approval Basis/Description: study evaluated the efficacy of NEXTSTELLIS in a prospective, multicenter, open-label, single-arm study in North America (NCT02817841; C302) of one-year duration that enrolled 1,674 females 16 to 35 years of age.

Qelbree

  • Brand Name: Qelbree
  • API: viloxazine
  • Company: Catalent Pharma Solutions
  • Patent status: New Molecular Entity
  • Approval Date: 4/2/2021
  • Indication: For the treatment of attention deficit hyperactivity disorder.

Approval Basis/Description: trial evaluated the efficacy of Qelbree in treating ADHD in pediatric patients 6 to 17 years of age in three short-term, randomized, placebo-controlled monotherapy trials.

Zegalogue

  • Brand Name: Zegalogue
  • API: dasiglucagon
  • Company: Zealand Pharma
  • Patent status: New Molecular Entity
  • Approval Date: 3/22/2021
  • Indication: To treat severe hypoglycemia in pediatric and adult patients with diabetes aged six years and above.

Approval Basis/Description: Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an anti-hypoglycemic effect.

New Drugs Approval: Ponvory

  • Brand Name: Ponvory
  • API: Ponesimod
  • Company: Janssen Pharmaceuticals
  • Patent status: New Molecular Entity
  • Approval Date: 3/18/2021
  • Indication: To treat patients with relapsing forms of multiple sclerosis.

Approval Basis/Description: PONVORY™ proved to reduce the average number of relapses per year.

PONVORY™ established to reduce the average number of new gadolinium-enhancing (GdE) T1 and new or enlarging T2 lesions. Supervision of this first dose should take place in a healthcare setting.

Fotivda

  • Brand Name: Fotivda 
  • API: Tivozanib
  • Company: AVEO Pharmaceuticals
  • Patent status: New Molecular Entity
  • Approval Date: 3/10/2021
  • Indication: To treat patients with renal cell carcinoma

Approval Basis/Description: FOTIVDA is indicated for treating adult patients with relapsed or refractory advanced renal cell carcinoma (RCC). The relapse of (R.C.C.) following two or more prior systemic therapies.

Novel Drugs Approval: Azstarys

  • Brand Name: Azstarys
  • API: serdexmethylphenidate and dexmethylphenidate
  • Company: Corium
  • Patent status: New Molecular Entity and Type 4 – New Combination
  • Approval Date: 3/2/2021
  • Indication: For the treatment of Attention Deficit Hyperactivity

Approval Basis/Description: AZSTARYS is a federally controlled substance (CII). Because it contains dexmethylphenidate that can target people who abuse prescription medicines or street drugs. 

AZSTARYS capsules are intended for oral administration. Each capsule contains a fixed molar ratio of 30% dexmethylphenidate and 70% serdexmethylphenidate.

Novel Drugs Approval: Pepaxto

  • Brand Name: Pepaxto
  • API: melphalan flufenamide
  • Company: Oncopeptides AB (publ), Stockholm, Sweden
  • Patent status: New Molecular Entity
  • Approval Date: 2/26/2021
  • Indication: For the treatment of certain patients with relapsed or refractory multiple myeloma.

Approval Basis/Description: PEPAXTO is an alkylating drug indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).

Nulibry (New Drugs Approval)

  • Brand Name: Nulibry
  • API: Fosdenopterin
  • Company: Origin Biosciences, Inc
  • Patent status: New Molecular Entity
  • Approval Date: 2/26/2021
  • Indication: To treat patients with the rare genetic disease molybdenum cofactor deficiency Type A

Approval Basis/Description: NULIBRY—shown to improve survival in patients with MoCD Type A. NULIBRY is a cyclic pyranopterin monophosphate (cPMP) for patients with MoCD Type A. NULIBRY replaces the critical component your child needs to make molybdenum cofactor (MoCo) since children with MoCD Type A can’t make it on their own.

F.D.A. approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A. This rare, genetic, metabolic disorder typically presents in the first few days of life, causing intractable seizures, brain injury, and death.

New Drugs Approval: Amondys 45

muscular dystrophy.
  • Brand Name: Amondys 45
  • API: Casimersen
  • Company: Sarepta Therapeutics, Inc.
  • Patent status: New Molecular Entity (Orphan)
  • Approval Date: 2/25/2021
  • Indication: For the treatment of Duchenne muscular dystrophy.

Approval Basis/Description: AMONDYS 45 is an antisense oligonucleotide. It is indicated for the treatment of Duchenne muscular dystrophy (D.M.D.) in patients with a confirmed mutation of the D.M.D. Gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued support for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. Amondys 45 is the first FDA-approved targeted treatment for patients with this type of mutation.

Cosela

  • Brand Name: Cosela
  • API: Trilacicilib
  • Company: G1 Therapeutics, Inc. 
  • Patent status: New Molecular Entity
  • Approval Date: 2/12/2021
  • Indication: To mitigate chemotherapy-induced myelosuppression in adult patients with small cell lung cancer.

Approval Basis/Description: F.D.A. approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme. 

New Drugs Approval: Evkeeza

  • Brand Name: Evkeeza
  • API: evinacumab-dgnb
  • Company: Regeneron Pharmaceuticals, Inc.
  • Patent status: Orphan
  • Approval Date: 2/11/2021
  • Indication: For the treatment of homozygous familial hypercholesterolemia.

Approval Basis/Description: EVKEEZA is an injectable prescription medicine used along with other low-density lipoproteins (LDL) lowering medications in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

  • It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol.
  • The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known.
  • It is unknown if EVKEEZA is safe and effective in children with HoFH under 12 years of age.

Novel Drugs Approval: Ukoniq

Ukoniq
  • Brand Name: Ukoniq
  • API: Umbralisib
  • Company: T.G. Therapeutics, Inc
  • Patent status: New Molecular Entity (Orphan)
  • Approval Date: 2/5/2021
  • Indication: For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma.

Approval Basis/Description: UKONIQ is a kinase inhibitor indicated for the treatment of adult patients with: 

  • • Relapsed or refractory marginal zone lymphoma (M.Z.L.) has received at least one prior anti-CD20-based regimen (1.1).
  •  • Relapsed or refractory follicular lymphoma (F.L.) has received at least three prior lines of systemic therapy (1.2). 

These indications are approved under accelerated approval based on the overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

New Drugs Approval: Tepmetko

lung cancer
  • Brand Name: Tepmetko
  • API: Tepotinib
  • Company: E.M.D. Serono, Inc., Rockland, MA 02370, U.S.A.
  • Patent status: New Molecule Entity (Orphan)
  • Approval Date: 2/3/2021
  • Indication: To treat non-small cell lung cancer.

Approval Basis/Description: TEPMETKO is a kinase inhibitor indicated for treating adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (M.E.T.) exon 14 skipping alterations. (1) This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Lupkynis

lupus nephritis
  • Brand Name: Lupkynis
  • API: Voclosporin
  • Company: Aurinia Pharmaceuticals Inc., Victoria, BC V8Z 7X8 Canada
  • Patent status: New Molecule Entity
  • Approval Date: 1/22/2021
  • Indication: To treat lupus nephritis.

Approval Basis/Description: LUPKYNIS is a prescription medicine used with other medicines to treat adults with active lupus nephritis. LUPKYNIS should not be taken with a drug called cyclophosphamide.

Novel Drugs Approval: Cabenuva

HIV
  • Brand Name: Cabenuva
  • API: cabotegravir and rilpivirine
  • Company: ViiV Healthcare
  • Patent status: New Molecule Entity (New Combination)
  • Approval Date: 1/21/2021
  • Indication: To treat H.I.V.

Approval Basis/Description: CABENUVA, a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. 

New Drugs Approval: Verquvo

Medicines for Heart Disorders
  • Brand Name: Verquvo
  • API: Vericiguat
  • Company: Bayer AG, Leverkusen, Germany
  • Patent status: New Molecule Entity
  • Approval Date: 1/19/2021
  • Indication: To treat chronic heart failure.

Approval Basis/Description: VERQUVO is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (H.F.) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic H.F. and ejection fraction less than 45%.

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