Amarin Corp Plc (AMRN)

[JBWIN]

JBWIN Wednesday, 01/27/21 08:29:35 AM
Re: BaaBaa45 post# 321387 0
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Typically, the CHMP monthly meeting run Monday to Thursday with the meeting highlights published on Friday. The Jan2021 meeting has been extended by one day covering the entire week, Monday to Friday, 25-29Jan2021. Thus, the outcome may be late Friday, over the weekend or, worst case, Monday morning.




Here is an example with the Dec2020 highlights:

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-december-2020#:~:text=EMA's%20human%20medicines%20committee%20(CHMP,metastatic%20HER2%2Dpositive%20breast%20cancer.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020 Share
News 11/12/2020
Fifteen new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 15 medicines for approval at its December 2020 meeting.

The Committee recommended granting a conditional marketing authorisation for Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. Enhertu was reviewed under EMA’s accelerated assessment programme.

The CHMP adopted a positive opinion for Heplisav B (hepatitis B surface antigen) for the active immunisation against hepatitis B virus infection.

Inrebic* (fedratinib) received a positive opinion for the treatment of primary myelofibrosis (an uncommon type of bone marrow cancer) and of myelofibrosis secondary to polycythaemia vera (a type of blood cancer) or essential thrombocythaemia (a rare chronic blood cancer).

The Committee recommended granting a marketing authorisation under exceptional circumstances for Lumoxiti* (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukaemia, a cancer of a type of white blood cell called B-lymphocytes.

The Committee recommended granting a conditional marketing authorisation for Retsevmo (selpercatinib) for the treatment of cancers that display a rearranged during transfection (RET) gene fusion: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer.

Rukobia (fostemsavir) received a positive opinion for the treatment of multidrug resistant HIV-1 infection.

The CHMP recommended granting a marketing authorisation for Sibnayal* (potassium citrate / potassium hydrogen carbonate) for the treatment of distal renal tubular acidosis, a rare genetic disorder that affects the ability of the kidneys to remove acid from the blood.

Tukysa (tucatinib) received a positive opinion for the treatment of HER2-positive locally advanced or metastatic breast cancer.

The CHMP recommended granting marketing authorisations for two biosimilar medicines: Kixelle (insulin aspart), for the treatment of diabetes mellitus; and Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.

The CHMP recommended granting marketing authorisations for four generic medicines: Lenalidomide Krka (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma; Lenalidomide Krka d.d. (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma; Lenalidomide Krka d.d. Novo mesto (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma; and Sunitinib Accord (sunitinib), for the treatment of cancer.

The CHMP recommended granting a marketing authorisation for Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.

Restriction of indication for Veklury

The CHMP adopted a positive opinion recommending a change to the product information for Veklury (remdesivir) to provide clearer instructions in which COVID-19 patients requiring supplementary oxygen it should be used. More information on the new indication is available on the summary of opinion document in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for Artobend (autologous human chondrocytes in vitro expanded) was withdrawn. This advanced therapy medicinal product (ATMP) was intended for the treatment of cartilage defects of the knee joint.

A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the December 2020 meeting is published on EMA's website. Minutes of the November 2020 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the December 2020 CHMP meeting are represented in the graphic below.

* This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.

CHMP statistics: December 2020

Positive recommendations on new medicines
Name of medicine Enhertu
INN trastuzumab deruxtecan
Marketing-authorisation applicant Daiichi Sankyo Europe GmbH
Therapeutic indication Treatment of metastatic HER2-positive breast cancer
More information Enhertu: Pending EC decision


Name of medicine Heplisav B
INN hepatitis B surface antigen
Marketing-authorisation applicant Dynavax GmbH
Therapeutic indication Active immunisation against hepatitis B virus infection
More information Heplisav B: Pending EC decision


Name of medicine Inrebic
INN fedratinib
Marketing-authorisation applicant Celgene Europe BV
Therapeutic indication Treatment of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
More information Inrebic: Pending EC decision


Name of medicine Lumoxiti
INN moxetumomab pasudotox
Marketing-authorisation applicant AstraZeneca AB
Therapeutic indication Treatment of relapsed or refractory hairy cell leukaemia
More information Lumoxiti: Pending EC decision


Name of medicine Retsevmo
INN selpercatinib
Marketing-authorisation applicant Eli Lilly Nederland B.V.
Therapeutic indication Treatment of cancers that display rearranged during transfection (RET) gene alterations: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer
More information Retsevmo: Pending EC decision


Name of medicine Rukobia
INN fostemsavir
Marketing-authorisation applicant ViiV Healthcare B.V.
Therapeutic indication Treatment of multidrug resistant HIV-1 infection
More information Rukobia: Pending EC decision


Name of medicine Sibnayal
INN potassium citrate / potassium hydrogen carbonate
Marketing-authorisation applicant Advicenne S.A.
Therapeutic indication Treatment of distal renal tubular acidosis
More information Sibnayal: Pending EC decision


Name of medicine Tukysa
INN tucatinib
Marketing-authorisation applicant Seagen B.V.
Therapeutic indication Treatment of HER2-positive locally advanced or metastatic breast cancer
More information Tukysa: Pending EC decision


Positive recommendations on new biosimilar medicines
Name of medicine Kixelle
INN insulin aspart
Marketing-authorisation applicant Mylan IRE Healthcare Limited
Therapeutic indication Treatment of diabetes mellitus
More information Kixelle: Pending EC decision


Name of medicine Yuflyma
INN adalimumab
Marketing-authorisation applicant Celltrion Healthcare Hungary Kft.
Therapeutic indication Treatment of certain inflammatory and autoimmune disorders
More information Yuflyma: Pending EC decision


Positive recommendations on new generic medicines
Name of medicine Lenalidomide Krka
INN lenalidomide
Marketing-authorisation applicant KRKA, d.d., Novo mesto
Therapeutic indication Treatment of multiple myeloma and follicular lymphoma
More information Lenalidomide Krka: Pending EC decision


Name of medicine Lenalidomide Krka d.d.
INN lenalidomide
Marketing-authorisation applicant KRKA, d.d., Novo mesto
Therapeutic indication Treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma
More information Lenalidomide Krka d.d.: Pending EC decision


Name of medicine Lenalidomide Krka d.d. Novo mesto
INN lenalidomide
Marketing-authorisation applicant KRKA, d.d., Novo mesto
Therapeutic indication Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma
More information Lenalidomide Krka d.d. Novo mesto: Pending EC decision


Name of medicine Sunitinib Accord
INN sunitinib
Marketing-authorisation applicant Accord Healthcare S.L.U.
Therapeutic indication Treatment of cancer
More information Sunitinib Accord: Pending EC decision


Positive recommendation on a new hybrid medicine
Name of medicine Ogluo
INN glucagon
Marketing-authorisation applicant XerisPharmaceuticals Ireland Limited
Therapeutic indication Treatment of severe hypoglycaemia in diabetes mellitus
More information Ogluo: Pending EC decision


Positive recommendations on extensions of indications
Name of medicine Bavencio
INN avelumab
Marketing-authorisation holder Merck Europe B.V.
More information Bavencio: Pending EC decision


Name of medicine Doptelet
INN avatrombopag
Marketing-authorisation holder Swedish Orphan Biovitrum AB (publ)
More information Doptelet: Pending EC decision


Name of medicine Iscover
INN clopidogrel
Marketing-authorisation holder sanofi-aventis groupe
More information Iscover: Pending EC decision


Name of medicine Keytruda
INN pembrolizumab
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Keytruda: Pending EC decision


Name of medicine Nplate
INN romiplostim
Marketing-authorisation holder Amgen Europe B.V
More information Nplate: Pending EC decision


Name of medicine Nordimet
INN methotrexate
Marketing-authorisation holder Nordic Group B.V.
More information Nordimet: Pending EC decision


Name of medicine Plavix
INN clopidogrel
Marketing-authorisation holder sanofi-aventis groupe
More information Plavix: Pending EC decision


Name of medicine Rinvoq
INN upadacitinib
Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG
More information Rinvoq: Pending EC decision


Name of medicine Spravato
INN esketamine
Marketing-authorisation holder Janssen-Cilag International N.V.
More information Spravato: Pending EC decision


Withdrawal of initial marketing authorisation application
Name of medicine Artobend
INN autologous human chondrocytes in vitro expanded
Marketing-authorisation applicant TETEC Tissue Engineering Technologies AG
More information Artobend: Withdrawn application


Other opinions
Name of medicine Veklury
INN remdesivir
Marketing-authorisation holder Gilead Sciences Ireland UC
More information Veklury: Pending EC decision