1℃October 09, 2018
Tag: teva , antibodies , CGRP Drug
Teva’s important asset—the migraine drug anti-CGRP antibody: AJOVYTM (fremanezumab-vfrm) was eventually marketed on September 14, 2018 after experiencing turbulence, to become the world’s 2nd anti-CGRP antibody approved for marketing, which has a more flexible way of drug use, and is priced comparably to the relevant drug of Amgen/Novartis. Refer to FDA Approved the Second Anti-CGRP New Drug for Migraine: Ajovy, with the Third One on the Way for the details. There are currently 7 noteworthy CGRP targeted drugs in the world. According to the forecast of EvaluatePharma, the global CGRP drug market will reach USD 5 billion by 2024, with 4 anti-CGRP antibodies ranking top 4 of the market. Here, this article mainly compares the clinical data of those 7 CGRP drugs, and forecasts the market size of CGRP drugs in the next 5 years.
Migraine has caused serious mental burden to patients, and anti-CGRP antibody is a class of drugs with quite definite mechanism of action therefor. There are currently 2 anti-CGRP antibody drugs marketed in CGRP drug market:
1. Aimovig (erenumab) of Amgen/Novartis was approved for marketing in May 2018, which became the first-in-class anti-CGRP monoclonal antibody drug, and is one of the high-profile drugs in 2018, with the price of USD 6,900/year.
2. Teva filed the marketing application for the anti-CGRP antibody: fremanezumab early in August 2017, and it used a priority review voucher, in the hope of ensuring fremanezumab to become the 2nd anti-CGRP antibody drug approved. The bug of Celltrion wasted the priority review voucher, however, fremanezumab was eventually marketed.
3. Furthermore, the anti-CGRP antibody: Emgality (galcanezumab) of Eli Lilly has been filed the marketing application, which may be approved for marketing on October 10, 2018 according to my forecast as per the review period of FDA.
Besides the above drugs marketed/filed for marketing, eptinezumab, rimegepant and ubrogepant, etc. are at the late clinical stages, and will be marketed successively in the future. Refer to the following table for the details:
Pharmaceutical product |
Type |
Company |
Stage |
Aimovig (erenumab) |
Antibody |
Amgen/Novartis |
Approved for marketing |
AJOVY (fremanezumab) |
Antibody |
Teva |
Approved for marketing |
Emgality (Galcanezumab) |
Antibody |
Eli Lilly |
Filed marketing application |
Eptinezumab |
Antibody |
Alder |
Phase III clinical trial |
Atogepant |
Small molecule |
Allergan Merck |
Phase II/III clinical trial |
Rimegepant |
Small molecule |
Bristol-Myers Squibb Biohaven |
Phase III clinical trial |
Ubrogepant |
Small molecule |
Allergan Merck |
Phase III clinical trial |
Small molecule drug vs Antibody drug:
Companies have successively published their key clinical data in the development of pharmaceutical products, which are summarized and compared here:
Drug |
Company |
Indication |
Effectiveness VS placebo |
Status |
Aimovig |
Amgen/Novartis |
Episodic/chronic migraine |
Episodic: -1.1 days Episodic: -1.4 to -1.9 days |
Marketed |
AJOVY |
Teva |
Episodic/chronic migraine |
Episodic: -1.5 days Chronic: -2.1 days |
Marketed |
Emgality |
Eli Lilly |
Episodic/chronic migraine |
Episodic: -1.8 to -1.9 days Episodic: -1.9 to -2.0 days Chronic: -2.0 days |
PDUFA 10 Oct. 2018 |
eptinezumab |
Alder |
Episodic/chronic migraine |
Episodic: -0.7 to -1.1 days Chronic: -2.7 days |
BLA H2 2018 |
Rimegepant |
Biohaven |
Episodic/chronic migraine |
75mg dose: -2h Pain relief rate: 19.2% vs 14.2%
|
Phase III |
Ubrogepant
|
Allergan |
Episodic/chronic migraine |
50mg dose: -2h Pain relief rate: 21.8% VS 14.3% |
NDA H1 2019 |
Atogepant |
Allergan |
Episodic/chronic migraine |
Episodic: 10mg, -1.1 days |
Phase III |
References: Evaluate Pharma, and official websites of companies |
It can be seen that:
1. The antibody drugs are generally administered once monthly through IV; small molecule drugs are taken orally and daily;
2. Efficacy of antibody drugs does not differ much; efficacy of small molecule drugs is also comparable;
3. Marketing sequence of a drug is crucial to its market share in the future.
According to the forecast of EvaluatePharma, size of the CGRP drug market will steadily grow from 2018 to 2024, and relevant antibody drugs will occupy the vast majority of the market share.
Forecast of Sales Data of CGRP Drug Market in 2018-2024:
CGRP市场销售数据预测 (亿美金) |
Forecast of Sales Data of CGRP Drug Market (USD 100 million) |
Reference: EvaluatePharma
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