BioCentury is providing this content for free given the urgent need for information about the coronavirus crisis. Further analysis can be found in our COVID-19 Resource Center. For more, sign up for our daily email.
1211 chmps
BioCentury & Getty Images

Regulation

CHMP’s December opinions include restrictions for Veklury in COVID, support for Daiichi, Seagen breast cancer drugs

Dec 12, 2020 | 1:26 AM GMT

In its December opinions, EMA’s CHMP recommended a restriction for Gilead’s Veklury, specifying that COVID-19 patients should be on low- or high-flow oxygen or other non-invasive ventilation at the start of treatment. 

The committee also backed Enhertu trastuzumab deruxtecan from Daiichi Sankyo Co. Ltd. (Tokyo:4568) and Tukysa tucatinib from Seagen Inc. (NASDAQ:SGEN), both to treat HER2-positive breast cancer; and Lumoxiti moxetumomab pasudotox from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) for relapsed or refractory hairy cell leukemia.

CHMP also issued a series of position opinions on label extensions, including a recommendation for Rinvoq upadacitinib from AbbVie Inc. (NYSE:ABBV) to treat psoriatic arthritis and ankylosing spondylitis.

Separately, Innate Pharma S.A. (Euronext:IPH; NASDAQ:IPHA) announced Friday it will return U.S. and European Lumoxiti commercialization rights, gained in 2018, to AZ. In a company statement, Innate CEO Mondher Mahjoubi said, “We’ve determined that there is low strategic value for us in maintaining Lumoxiti in our portfolio due to lower than anticipated product sales, further compounded by the ongoing COVID-19 pandemic."

The French biotech will refocus its investments on its R&D portfolio.

Innate lost €0.85 (20%) to €3.49 in Paris and $0.96 (18%) to $4.36 in New York on Friday.

TARGETS
CD22 (SIGLEC2)
CD110 (Mpl) – Thrombopoietin receptor
HBsAg – Hepatitis B surface antigen
HER2 (EGFR2; ErbB2; neu) – Epidermal growth factor receptor 2
JAK-1 – Janus kinase-1
JAK-2 – Janus kinase-2
PD-L1 (B7-H1; CD274) Programmed cell death 1 ligand 1
TNF – Tumor necrosis factor
TROP2 (TACSTD2; EGP-1) – Tumor-associated calcium signal transducer 2

How to gain access

Continue reading with a
two-week free trial.