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FDA grants accelerated nods to J&J, Pfizer’s blood cancer therapies; Ipsen’s rare disease drug approved
This was a week of drug approvals. The US Food and Drug Administration (FDA) granted accelerated approvals to two cancer therapies — Talvey by Johnson & Johnson (J&J) and Elrexfio by Pfizer. The agency also approved Ipsen’s rare bone disorder drug Sohonos, and Janssen’s Akeega (niraparib and abiraterone acetate) for the treatment of adult patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). Additionally, the agency approved Revance Therapeutics’ Daxxify as the first long-acting treatment for cervical dystonia.
Following last week’s promising update on Novo’s obesity drug Wegovy, which lowers heart attack risks by 20 percent, there are more updates this week from the drugmaker. The company is acquiring Canadian obesity drugmaker Inversago for up to US$ 1.08 billion. Its obesity drug Wegovy’s sales increased by over 30 percent during the last quarter to touch Danish Krone (DKK) 7.5 billion (US$ 1.1 billion).
In dealmaking news, Gilead has entered into three multi-year collaborations with Tentarix Biotherapeutics to develop novel therapies for cancer and inflammatory diseases. And a combination of Seagen’s therapy Tukysa and Roche’s Kadcyla met the main goal in some breast cancer patients in a late-stage study. Seagen was bought over by Pfizer for US$ 43 billion in March this year.
J&J, Pfizer’s cancer therapies bag FDA’s accelerated approvals
Johnson & Johnson’s pharmaceutical unit Janssen has received FDA’s accelerated approval for Talvey (talquetamab-tgvs), a first-in-class bispecific antibody therapy designed to treat adult patients dealing with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. Talvey, a weekly or biweekly subcutaneous injection, works by targeting a protein GPRC5D. The company expects the therapy to be accessible to patients within a span of three weeks. Talvey will be marketed at a list price of US$ 45,000 per month.
FDA has also granted accelerated approval to Pfizer’s blood cancer treatment, Elrexfio (elranatamab-bcmm). This therapy is the first ready-to-use subcutaneous B-cell maturation antigen-directed agent in the US designed for adults with RRMM, a difficult-to-treat type of blood cancer. Elrexfio will carry list prices of US$ 7,556 and US$ 13,051 for the 44 mg and 76 mg vials respectively.
In addition, the agency has also granted approval to Janssen’s Akeega (niraparib and abiraterone acetate), a fixed dose combination given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), as detected by an FDA-approved test.
Novo to acquire Inversago Pharma for up to US$ 1.08 billion
Novo Nordisk will acquire Canada-based Inversago for up to US$ 1.075 billion in cash, contingent upon the achievement of specific development and commercial goals. Through this acquisition, Novo will gain access to Inversago’s primary developmental asset INV-202, an oral cannabinoid receptor blocker. In an early stage trial, INV-202 displayed the potential for weight loss and is presently undergoing a mid-stage trial to address diabetic kidney disease. The company aims to explore the possible applications of INV-202 in treating obesity and its associated complications. Furthermore, Inversago is actively working on additional pipeline assets designed for metabolic and fibrotic disorders.
In its second quarter (Q2) results, Novo Nordisk reported 158 percent sales growth in the segment of obesity, with Wegovy contributing DKK 7.5 billion (approximately US$ 1.1 billion). The total revenue increased 30 percent, reaching DKK 107.7 billion (US$ 15.8 billion) as compared to the previous year.
Meanwhile, Novo is further evaluating results from Wegovy’s five-year trial for additional health advantages in areas such as kidney disease, heart failure, and the likelihood of hospitalization. The company plans to seek regulatory approval for incorporating the cardiovascular advantage into the drug’s label.
FDA okays Ipsen’s rare bone disorder drug — Sohonos
FDA has approved Ipsen’s drug to treat fibrodysplasia ossificans progressiva (FOP), a rare genetic connective tissue disorder that causes progressive loss of mobility and reduced life expectancy. The drug — Sohonos — was approved in adults and pediatric patients with FOP.
Meanwhile, Peter Marks, FDA’s biologics center director told Endpoints News that “the agency plans to encourage sponsors to use the accelerated approval pathway”, particularly for rare disease treatments, as the agency also moves ahead with an Operation Warp Speed-like pilot for rare diseases later this year.
FDA approves Revance’s Daxxify as first long-acting treatment for cervical dystonia
FDA has approved Revance Therapeutics’ Daxxify (daxibotulinumtoxinA) as the first long-acting treatment for cervical dystonia, a rare condition in which the neck muscles involuntarily contract into abnormal positions in adults. It is the first and only peptide-based, long-acting neuromodulator designed to address patients’ needs for improved treatment outcomes. Daxxify received orphan drug designation from the FDA for treating cervical dystonia in adults in 2017. It was further approved as an anti-wrinkle injection in September 2022, competing with AbbVie’s Botox.
Seagen’s Tukysa meets main goal in breast cancer study: A combination of Seagen’s therapy, Tukysa and Roche’s Kadcyla (ado-trastuzumab emtansine) met the primary endpoint of progression-free survival in a late-stage study on some breast cancer patients. The study reported that the combination extended the patient’ lives without their disease worsening. Seagen was bought over by Pfizer for US$ 43 billion in March this year.
Gilead partners with Tentarix for cancer, inflammatory treatments
Gilead Sciences has entered into three multi-year collaborations with Tentarix Biotherapeutics to develop novel therapies for cancer and inflammatory diseases. Tentarix will get upfront payments and equity worth US$ 66 million from Gilead. The latter also has the option to acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for US$ 80 million per subsidiary. The agreement provides Gilead access to Tentarix’s proprietary drug development platform known as Tentacles, dedicated to the discovery and formulation of multi-functional, conditional protein therapeutics for both cancer and inflammatory diseases.
Harmony to acquire Zynerba for US$ 200 million: Harmony Biosciences will acquire Zynerba Pharmaceuticals for up to US$ 200 million upfront, in a bid to deepen and diversify its portfolio, particularly in rare neuropsychiatric disorders. This buyout gives Harmony access to Zynerba’s lead asset Zygel, the first and only pharmaceutically manufactured, synthetic non-euphoric cannabidiol gel for transdermal delivery. It is currently in a late-stage trial for Fragile X syndrome, a genetic disorder for which there are no approved therapies.
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