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Analysis of New Drug Approval of FDA in 2017 Q1: Drugs Approved in the 3 Months were Nearly Half of

April 14, 2017 By en-cphi.cn

2017 is a year worth expecting, with the innovative drug development nonstop.  At the beginning of April after the first quarter of this year just ended, I would like to analyze the drugs approved by FDA in the first quarter. FDA approved 12 new drugs (see the attached table for the details) in total in 2017 Q1, including 8 NMEs (new molecular entity) and 4 BLAs (biologics license application). The quantity approved apparently higher than that of the same period in 2016. I would like to make a generalization of those 12 drugs here.

I. Potential blockbuster drug prediction: Which will be the future blockbuster?

One tag of blockbuster drugs is the annual sales of over USD 1 billion. Blockbuster drugs are a powerful competition chip for pharmaceutical enterprises. Some among the 12 new drugs marketed in 2017 Q1 receive much attention from the market and possess much potential to become blockbuster drug. An article of Endpoint News forecast 15 would-be blockbusters in 2017, including Novartis’ Kisqali, TESARO’s Zejula, Sanofi’s Dupixent, and Roche’s Ocrevus.

1. Novartis’ Kisqali is a CDK4/6 inhibitor, has received breakthrough therapy designation and priority review, and brings an innovative therapy to HR+/HER2- metastatic breast cancer patients, with the peak revenue to possibly reach up to USD 1.5 billion;

2. TESARO’s Zejula is a PARP inhibitor, has distinct advantages over similar drugs, and can clinically significantly improve the progression free survival of recurrent ovarian cancer patients without inspection of BRCA mutation or other biomarker condition, with the forecast peak revenue to reach USD 1.79 billion;

3. Sanofi’s Dupixent also has bright market prospects, and is the first monoclonal antibody drug used for patients with eczema that is not well controlled; the drug has received much attention from the beginning of marketing (see New Drug of Sanofi/Regeneron Receiving Much Attention from the Beginning of Marketing: With Both Positive Market Prospects and Patent Litigation Risk for details), and is forecast to reach USD 4.1 billion sales in 2022 by EvaluatePharma;

4. Roche’s Ocrevus is also a game changing drug, is the first clinical therapeutic drug used for primary progressive multiple sclerosis, and is expected to become first choice of second or third line drugs, with the peak revenue expected to be USD 3.98 billion.

II. 5 drugs received priority review: Many breakthrough drugs were approved.

Adopting the accelerated approval policy for innovative drugs, breakthrough therapies and rare disease drugs, FDA offers the common accelerated approval measures including breakthrough therapy designation, priority review, fast track and orphan drug status, which is of great significance to the fast marketing of innovative drugs that are clinical imperative. According to statistics, 25% (3 new drugs) drugs received breakthrough therapy designation, 42% (5 drugs) approved drugs received priority review, 33% (4 drugs) reviewed drugs received fast track, and 25% (3 drugs) drugs received orphan drug status, being of great significance to fast marketing of innovative drugs and treatment and prevention of rare diseases.

FDA has always been the wind vane for review and approval of world’s innovative drugs. And it’s very important to pay close attention to the pharmaceutical approval dynamics, policy innovation, and drug safety. The marketing and market performance of drugs in the U.S. market are of great reference value to their future trend in the Chinese pharmaceutical market.
 

Trade name

Generic name

Company

Mechanism of action

Indication

Approval time

Explanation

Trulance

Plecanatide

Synergy

Uroguanylin analog that stimulates secretion of fluid and changes stool consistency

Chronic Idiopathic Constipation (CIC)

January 19, 2017

NME, the first new drug mimicking in vivo uroguanylin function

Parsabiv

Etelcalcetide

Amgen

Acting on calcium-sensing receptor and regulating parathyroid hormone secretion

Secondary hyperparathyroidism

February 8, 2017

NME, the only calcimimetic that can be administered intravenously three times a week at the end of the hemodialysis session

Emflaza

Deflazacort

Marathon pharmaceuticals

Corticosteroid precursor: active metabolite of 21-desDFZ, exerting anti-inflammatory and immunosuppressive effects through glucocorticoid

Duchenne muscular dystrophy (DMD)

February 9, 2017

NME, priority review, fast track, and orphan drug status

Siliq

Brodalumab

Valeant Pharmaceuticals

Targeting the IL-17 receptor

Moderate-to-severe plaque psoriasis

February 15, 2017

BLA, providing another treatment choice for patients with moderate-to-severe plaque psoriasis

Xermelo

Telotristatethyl

Lexicon Pharmaceuticals

Acting on tryptophan hydroxylase to reduce the frequency of diarrhea

Carcinoid syndrome diarrhea

February 15, 2017

NME, fast track, priority review, and orphan drug status

Kisqali

Ribociclib

Novartis

CDK4/6 inhibitor

Postmenopausal women with HR+/HER2- advanced/metastatic breast cancer

March 13, 2017

NME, breakthrough therapy designation and priority review

Xadago

Safinamide

Newron pharmaceuticals

Selective monoamine oxidase B (MAO-B) inhibitor, improving the exercise capacity decline of patients with Parkinson's disease (PD) experiencing "off" episodes

Parkinson’s disease

March 21, 2017

NME, the first new chemical entity approved for PD in the U.S. over the decade

Bavencio

Avelumab

Merck/Pfizer

Anti-PD-L1 monoclonal antibody

Metastatic Merkel cell carcinoma

March 23, 2017

BLA, world's first anti-PD-1/PD-L1 immunotherapy approved for metastatic Merkel cell carcinoma; breakthrough therapy designation, fast track, orphan drug status and priority review

Symproic

Naldemedine

Shionogi/purdue pharma

Opioid receptor antagonist, for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain

Opioid-induced constipation

March 23, 2017

NME, providing a safe and effective treatment choice for patients with chronic non-cancer pain and opioid-induced constipation

Zejula

Niraparib

TESARO

Poly ADP-ribose polymerase (PARP) inhibitor, able to inhibit cells' repair of DNA damage

Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

March 27, 2017

NME, fast track, breakthrough therapy designation and priority review; the first PARP inhibitor that can clinically significantly improve the progression free survival of recurrent ovarian cancer patients without inspection of BRCA mutation or other biomarker condition

Dupixent

Dupilumab

Sanofi

Targeting IL-4Rα, specifically inhibiting overactive signaling of Interleukin-4 (IL-4) and Interleukin 13 (IL-13)

Atopic dermatitis

March 28, 2017

BLA, the first monoclonal antibody drug approved for patients with moderate-to-severe eczema that is not well controlled

Ocrevus

Ocrelizumab

Roche

Targeting CD20, being a humanized monoclonal antibody

Relapsing and primary progressive forms of multiple sclerosis

March 28, 2017

BLA, the first clinical therapeutic drug used for primary progressive multiple sclerosis

 

 

 

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