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Pfizer's Herceptin biosimilar, 8 other drugs recommended for EU approval

The European Medicines Agency recommended the approval of nine new therapies this month, including Pfizer Inc.'s Trazimera, a biosimilar of Roche Holding AG's breast cancer drug Herceptin.

Trazimera is indicated for treating breast and gastric cancer that has spread to other parts of the body, as well as HER2-positive early breast cancer.

The EU agency's Committee for Medicinal Products for Human Use, or CHMP, also granted a positive opinion to Novartis AG's Aimovig, a new class of medicines that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

The committee recommended granting marketing authorization to Ionis Pharmaceuticals Inc.'s Tegsedi for treating stage 1 or stage 2 polyneuropathy, or damaged peripheral nerves, in patients with inherited transthyretin amyloidosis.

Hereditary transthyretin amyloidosis is a rare, progressive disease characterized by an abnormal buildup of the amyloid protein in the body's organs and tissues.

The EMA also backed the approval of Novartis' Halimatoz, Hefiya and Hyrimoz, which are biosimilar versions of AbbVie Inc.'s Humira indicated for use in treating certain inflammatory and autoimmune disorders, including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

The CHMP issued a positive opinion to Myalepta, a drug from Novelion Therapeutics Inc.'s Aegerion Pharmaceuticals unit, for treating leptin deficiency, a condition that causes severe obesity starting in the first few months of life.

The panel also recommended approving Rxulti, Otsuka Pharmaceutical Co. Ltd.'s treatment for adult patients with schizophrenia.

One generic medicine won the committee's positive recommendation: Cycle Pharmaceuticals Ltd.'s Nityr intended for treating inherited tyrosinemia type 1, a rare metabolic disorder characterized by high levels of amino acid tyrosine in the blood due to the lack of fumarylacetoacetate hydrolase enzyme.

The committee issued a negative opinion for Sarepta Therapeutics Inc.'s Exondys intended to treat Duchenne muscular dystrophy. The company has requested a re-examination of the negative opinion.

Meanwhile, Allergan PLC withdrew its application to market Restaysis, the company's dry eye disease drug.

Furthermore, AB Science SA withdrew its request to re-examine the CHMP's negative opinion on Alsitek, a drug intended to treat amyotrophic lateral sclerosis, or ALS, a group of rare neurological diseases affecting nerve cells in the brain and spinal cord.