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The US Food and Drug Administration (FDA) has approved GSK’s Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis patients with anaemia. The intermediate or high-risk myelofibrosis patients include individuals with primary or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia).

Ojjaara is a once-daily Janus kinase (JAK)1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor initially developed by Sierra Oncology. Ojjaara was included in GSK’s portfolio after the acquisition of Sierra in 2022. 

The commonly prescribed FDA-approved treatment for myelofibrosis includes Novartis and Incyte’s Jakafi (ruxolitinib). Jakafi generated $1.2bn in global sales in H1 2023, as per Incyte’s Q2 financial report.GlobalData forecasts Ojjaara to have modest sales of $499m in 2029 compared to Jakafi’s sales of $3.1bn in the same period.

The approval is based on the two Phase III studies, Momentum (NCT04173494) and Simplify-1 (NCT01969838) which compared Ojjaara to other myelofibrosis therapies, danazol and Jakafi, respectively. 

Novartis has confirmed plans for the complete spin-off of its generics and biosimilars business, Sandoz, following approval from shareholders. New Sandoz Group shares and American depositary receipts (ADRs) will begin trading on 4 October 2023.

Sandoz will be included in the Swiss Performance Index, the Swiss Leader Index and other Swiss indices.

The latest development follows the company’s announcement in August 2022 of plans to separate the Sandoz business and establish an independent company.

Sandoz obtained $3.75bn (SFr3.42bn) in debt financing from a number of banks that will provide $1.25bn via a revolving credit facility, which will serve as an undrawn backstop provision. The spin-off will conclude with the distribution of Sandoz shares and ADRs in a 1:5 ratio to Novartis shareholders and ADR holders, respectively.

In a press release, Novartis noted: “Completion of the proposed spin-off is subject to satisfaction of certain conditions, including no event outside of the control of Novartis preventing the spin-off and no material adverse change. 

Pfizer has received marketing authorisation from the European Commission (EC) for LITFULO (ritlecitinib) for the treatment of adults and adolescents aged 12 years and above with severe alopecia areata.

LITFULO’s marketing authorisation is accepted in all 27 EU member states, as well as in Norway, Liechtenstein and Iceland.

The once-daily oral capsule is said to be the first and only treatment to selectively prohibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. Its approval was based on data from the ALLEGRO clinical trial programme, which included the ALLEGRO Phase IIb/III study.

The trial assessed LITFULO for this indication in patients with 50% or more scalp hair loss, including those with alopecia universalis (total body hair loss) and alopecia totalis (total scalp hair loss). Results demonstrated that following 24 weeks of treatment with LITFULO 50mg, 13.4% of adults and adolescents experienced 90% or more scalp hair coverage, compared with 1.5% with a placebo.

The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s supplemental biologics license application (sBLA) for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

The vaccine is indicated for use in people aged 12 years and above.

The regulator also granted emergency use authorisation (EUA) for the vaccine’s use in children aged six months to 11 years. This vaccine for the season is recommended for use as a single dose in most people aged five years and above.

For children aged below five years, additional vaccine doses can be given if they were not previously inoculated with a three-dose vaccine regimen.

The latest FDA decision comes after its Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided guidance recommending approval for an Omicron XBB.1.5-adapted monovalent Covid-19 vaccine for the fall and winter season in 2023 and 2024.

Pfizer and BioNTech were producing the 2023–2024 Covid-19 vaccine at risk to guarantee prompt supply.

Novartis has announced that the Phase III NETTER-2 trial of the combination therapy of Lutathera (lutetium Lu 177 dotatate) and a long-acting octreotide met its primary endpoint.

Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. It was first approved by the FDA as a combination therapy with a long-acting octreotide for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in 2018.

NETs are rare tumours that develop in the cells of the neuroendocrine system, which are present throughout the body. Half of the NET tumours start in the gastrointestinal system and can be either benign or neoplastic, as per Cancer Research UK. The standard treatment for NETs is either surgical management or somatostatin analogues (SSAs) therapy.

GlobalData forecasts the NET market to grow to $3.42bn in 2030 across eight major markets.

Novartis is expected to control up to half of the market with its extensive portfolio, including SSA therapy Sandostatin (octreotide).