Amarin Corp Plc (AMRN)

[JBWIN]

Vascepa/Icosapent Ethyl was on the CHMP agenda for the December meeting held 7-10Dec2020 under the section "Initial applications; List of Outstanding Questions" not yet moving to the point of positive opinion/recommendation, which leads to full European Commission (EC) approval 60 days later.

Vascepa was originally on for List of Outstanding Questions during the Sep2020 CHMP meeting. Given the potential millions of potential CVD patients, it is not shocking to see additional questions that need to be answered, though JT's language about label and support from two European medical societies in advance of the approval suggests we are very close. My expectation is CHMP positive opinion during Jan2021 or Feb2021 meetings and EC approval Mar2021 or Apr2021.


Note that the original timing of end of year was mentioned in the PR and many applications took a bit longer due to the pandemic.

https://www.globenewswire.com/news-release/2019/12/02/1954582/0/en/European-Medicines-Agency-Accepts-for-Review-Marketing-Authorization-Application-for-Amarin-s-Icosapent-Ethyl-Vascepa-for-Reduction-of-Cardiovascular-Risk-in-High-Risk-Patients-as-.html

To illustrate that it is not uncommon for a second meeting to deal with outstanding questions, please note the following that fell into that category for the Dec2020 meeting:

3.2.3. bevacizumab - EMEA/H/C/005286

Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer.
First-line treatment of patients with unresectable advanced, metastatic or recurrent non- small cell lung cancer.

First line treatment of patients with advanced and/or metastatic renal cell cancer.

Scope: List of outstanding issues

Action: For adoption

List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.


3.2.6. duvelisib - Orphan - EMEA/H/C/005381

Verastem Europe GmbH; treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and relapsed or refractory follicular lymphoma (FL).

Scope: List of outstanding issues
Action: For adoption
List of Outstanding Issues adopted 17.09.2020. List of Questions adopted on 30.04.2020.

3.2.8. ofatumumab - EMEA/H/C/005410

treatment of relapsing forms of multiple sclerosis. Scope: List of outstanding issues,
list of questions to the SAG
Action: For adoption

List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.

3.2.10. bevacizumab - EMEA/H/C/005556

Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer.

First-line treatment of patients with unresectable advanced, metastatic or recurrent non- small cell lung cancer.

First line treatment of patients with advanced and/or metastatic renal cell cancer.

Scope: List of outstanding issues

Action: For adoption

List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.


3.2.15. icosapent ethyl - EMEA/H/C/005398

indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Scope: List of outstanding issues

Action: For adoption

List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 26.03.2020.

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