In December, 5 innovative drugs may be approved for marketing!

In November, the FDA approved a total of 5 new drugs, including Tzield, the world's first innovative anti-diabetes delaying therapy, Hemgenix, the first hemophilia B gene therapy, Sezaby (phenobarbital sodium), the anti-tumor ADC drug ElahereTM, and the CTLA-4 monoclonal antibody Imjudo (tremelimumab).

Looking forward to December, some institutions predict that another 5 innovative drugs may be approved by the US FDA
.
Toripalimab and Coherus' toripalimab are anti-PD-1 monoclonal antibodies that specifically bind to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, and reactivating the anti-tumor activity of lymphocytes to treat cancer
。 The drug has received priority review from the FDA for two indications: first, in combination with gemcitabine and cisplatin for first-line treatment in patients with advanced recurrent or metastatic nasopharyngeal carcinoma; The second is as a single agent for the second-line or late-stage treatment
of patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed to platinum-containing chemotherapy or disease progression after chemotherapy.
Lenacapavir of Gilead Sciences applied to the FDA for approval to treat infections in patients with multidrug-resistant (MDR) HIV-1 infection with severe treatment experience (HTE
).
Enacapavir is an HIV-1 cap inhibitor administered by medical professionals and injected
subcutaneously every six months along with other antiretroviral drugs.
Lenacapavir seeks approval on the basis of the clinical trial CAPELLA, a Phase 2/3 placebo-controlled study that met the primary endpoint
.
Specifically, the FDA received the drug's resubmitted NDA application in July this year, and the PDUFA date is set for December 27
, 2022.
Ublituximab TG Therapeutics' Ublituximab is indicated for multiple sclerosis (MS), a sugar-engineered monoclonal antibody that targets a unique epitope
on the CD20 antigen expressed by B cells.
The FDA is reviewing paclitaxel
used by TG Therapeutics to treat recurrent multiple sclerosis.
TG's application is based on two Phase III clinical trials, ULTIMATE 1 and ULTIMATE 2, evaluating annual recurrence rate (ARR) as its primary endpoint, seeking approval
.
Palovarotene is indicated for progressive muscular ossification by Ipsen, a selective retinoic acid receptor γ (RARγ) agonist
.
The FDA received the NDA application for the drug and granted it priority review status at the end of June this year, with a PDUFA date set for December 29
, 2022.
The FDA granted Ipsen/Clementia's palovarotene priority review
for the prevention of ectopic ossification (new bone formation) in patients with fibrodysplasia (FOP).
Palovarotene is seeking approval based on an open-label, phase 3 single-treatment trial in which all subjects received doses of palovarotene to evaluate safety and dosing regimens
.
Mosunetuzumab mosunetuzumab, a Roche genentech company, is indicated for follicular lymphoma (FL), a T-cell artigated bispecific antibody
that targets the CD20 antigen on the surface of B cells and the CD3 receptor on the surface of T cells.
The FDA received the drug's BLA application and granted priority review status in early July this year, and the PDUFA date is set for December 29
, 2022.
The FDA granted Genentech's mosunetuzumab priority review rights for the treatment of relapsed or refractory follicular lymphoma (FL) in adult patients who had previously received at least two systemic treatments
.
Follicular lymphoma, an indolent (slow-growing) form of common non-Hodgkin lymphoma (NHL), is a type of blood cancer that often recurs
after initial treatment.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.