This month the EU CHMP recommended 5 new drugs on the market! Includes Roche Xofluza, Samsung Onbevzi

On November 14th, the European Medicines Agency (EMA) Human Medicines Commission (CHMP) recommended the approval of five drugs at its monthly meeting, one of which was approved after a re-examination and an extension of the approval application for six drugs.
, CHMP issued a non-recommendation after a review, and three companies withdrew their marketing applications.
new drug actively recommended: Phesgo (pertuzumab/trastuzumab) for the treatment of early and metastasis HER2-positive breast cancer.
this drug from Roche is a fixed dose of Pertuzumab (pertuzumab) and Herceptin (trastuzumab, trastuzumab) combined with hyaluronoidase (hyaluronidase) and used by subsurface injection.
Roclanda (latanoprost/netarsudil) is used to reduce high eye pressure (IOP) in adult primary open-angle glazing or high eye pressure patients, who experience insufficient eye pressure reduction due to the single use of latatin or nettarsudil.
eye potion from Aerie Pharmaceuticals is currently called Rocklatan in the U.S. market.
Xofluza (baloxavir-marboxil) to treat people 12 years of age and older with simple influenza.
the oral antiviral drug from Roche is also recommended for influenza prevention treatment in people 12 years of age and older.
Onbevzi, a biosimilar from Samsung Biotech, is a biosimilar of Roche Avastin (bevacizumab) for the treatment of colon, rectal, breast, non-small cell lung, renal cell carcinoma, ovarian epithelial cancer, fallopian or primary peritiotic cancer and cervical cancer.
recommended after retrouting: Elzonris (tagraxofusp) is used to treat primary plasma cell-like synaptic cell tumors (BPDCN), regardless of whether the patient has previously received other medications.
CHMP initially rejected an application from Menarini in July, and after a re-examination CHMP recommended that it be approved for listing for BPDCN patients in exceptional circumstances, their use should be restricted for patients who have not received any treatment.
not recommended after retesting: Gamifant (emapalumab) is used to treat primary phagocytosis (HLH) in children under 18 years of age.
CHMP gave a negative opinion in July, but Swedish pharmaceutical company Swedish Orphan Biovitrum called for the decision to be reviewed.
reassessing its application, CHMP confirmed earlier recommendations that the drug's research data were "insufficient" to conclude that the interferon γ blocking antibody was effective for HLH treatment.
actively recommends drug extension therapy adaptation certificate: anthon Kyprolis (carfilzomib) in combined use with daratumumab (Daremu monoanti) and dexamisong, in ligandsan and dexamisong, or in a separate joint use with dexamysund, for adult multiple myeloma patients who have previously received at least one treatment.
new drug forms and dosages of dabigatran etexilate (dabigatran etexilate) - 20 mg, 30 mg, 40 mg, 50 mg, 110 mg and 150 mg doses of coated particles, as well as oral solution and solvents at doses of 6.25 mg/mL.
CHMP also supports the approval of the drug for the treatment of venous thromboembolism events (VPTs) and the prevention of VTE recurrence in pediatric patients from birth to under 18 years of age, and proposes new taboos for use in adult patients with severe kidney damage and in pediatric patients with eGFR less than 50 mL/min/1.73m2.
ViiV Healthcare's integrated enzyme chain transfer inhibitor, Dolutegravir, is a dispersive tablet formulation that is used in association with other antiretroviral drugs to treat HIV-1 infections in pediatric patients who are at least 4 weeks old and weigh at least 3 kg.
positive comments from CHMP also include the latest dosage recommendations for Tivicay film coating tablets for children 6 years of age and older weighing at least 14 kg.
Chiesi Farmaceutici's Trimbow (beclometasone/formoterol/glycopyronium bromide, pyclomisone/formotro/grombominium) is used for maintenance therapy for asthma and is suitable for adults who have not been treated with long-acting beta-2 subjectors and large doses of inhaled corticosteroid maintenance, as well as adults who experienced one or more asthma deteriorations in the previous year.
Bayer oral Xa factor inhibitor Xarelto (rivaroxaban, Devasaban) is used to treat VTE and prevent the recurrence of VTE in children born to children under 18 years of age with VTE, including catheter-related thrombosis, cerebral vein and sinus thrombosis.
(UCB) Xyrem (sodium oxybate, sodium oxybate) is used to treat narcostic sleeping sickness in adolescents and children under 7 years of age.
withdrawal of the application: On 28 October, Santhera Pharmaceuticals withdrew a listing application for the treatment of Duchenne muscular dystrophy in Puldysa.
month, the company decided to halt the development of Puldysa, a drug that was shown to be ineffective in a Phase 3 clinical study of DMD patients.
BioMarin Pharmaceutical withdrew its application for approval of Roctavian gene therapy for the treatment of patients with severe haemophilia A.
said it could not provide the requested data to address "significant objections" from the regulator's High Therapeutics Committee over clinical findings "in the current process."
the gene therapy was rejected by the FDA before it was withdrawn.
Agios company Tibsovo (ivosidenib) is used to treat relapse or refractic acute myeloid leukemia with IDH1 mutations.
announced in October that CMHP did not believe the data from its Phase 1 clinical study supported the positive benefits-risk balance of the proposed adaptation, and subsequently withdrew its application for approval for the drug.
source: Recommendations for five new drugs lead decisions from CHMP's November meeting Original title: 5 new drugs recommended by EU CHMP this month! Roche Xofluza, Beval bead single anti-biosimilars...