Saphnelo
(anifrolumab-fnia) is the second targeted lupus therapy that has received FDA
approval. Saphnelo reduces the activity of the Type 1 Interferon Receptor,
which may be important in the disease process. Saphnelo is approved for direct
delivery in veins, but many patients with lupus continue to seek additional
treatment options. Lupus therapeutics continue to evolve and the FDA remains
committed to working with researchers and drug developers to find the right
drugs for lupus patients.
A recent
study from Pharma Point suggests that there is potential for an increase in
available therapeutic options for patients, particularly those that are safe
and offer potent clinical benefits. In addition, researchers expect the
introduction of seven biological therapies in 2012-2022, changing the
competitive landscape and expanding the lupus
therapeutic market. It is estimated that these new therapies
will help patients manage their disease better and prevent flares from
reoccurring.
Recent
publications describe the use of novel immunoregulatory DNA sequences to combat
autoantibodies. These molecules inhibit the activation of Toll-like receptors
and significantly reduce autoantibody production in mice. These drugs are aimed
at the autoantigens and cell surface molecules that cause lupus. They have also
been shown to reduce proteinuria and increase survival. The emergence of these
new therapeutics is an exciting development in the lupus market. Conventional
lupus drugs are associated with significant adverse effects, including
recurrent infections and cancer. The primary reason is the general
immunosuppression caused by the drugs. Patients with lupus may also suffer from
unpredictable lupus flares and nonresponders. Nonetheless, the research shows
that immunosuppressive medication can effectively relieve kidney inflammation.
It may even help prevent blood clots in patients who have lupus. Inorganic
growth strategies are expected to gain traction in the global lupus therapeutic
market in the coming years. Companies are likely to make use of M&A
activities and industrial-academia collaborations to increase their market
share and expand their pipelines. Another example of this is GlaxoSmithKline
plc's acquisition of Human Genome Sciences to develop a drug called BENLYSTA.