Over time FDA approves some drugs to be used to treat different diseases. Almost every month new drugs are approved. There are a lot of research happening at the moment, and usually, most of these research lead to the development of better medications. There are new products that FDA approved in July 2017. Here the four products that the FDA approved in July.
The FDA approved the subcutaneous formulation of Benlysta for treatment of Systematic Lupus Erythematosus for adult patients receiving standard therapy. A systematic lupus erythematosus is a form of lupus which is a chronic autoimmune disease that produces antibodies that attack every part of the body. This approval marked the first self-injection treatment for patients with systematic lupus erythematosus.
The patients have to train with their health care provider, and after that, they can administer the medicine on a weekly basis. The medication involves an injection of 200mg of the medicine once every week. Patients can have the medication from a single dose autoinjector or single dose prefilled syringe.
This approval makes the second Benlysta formulation approval for SLE. Intravenous (IV) formulation was approved in 2011. This formulation can only be administered by a healthcare professional. The administration of the formulation takes one hour and can be done in a clinic or hospital setting and is done every four weeks. Lupus has affected many patients in different ways and usually have unpredictable symptoms. Since its approval in 2011, Benlysta has offered treatments to many patients.
The approval of self-injecting form will offer an extra option for the patients. Patients don’t have to go the hospital or clinic again for the infusions. Benlysta has not been investigated in patients with severe active central nervous system lupus and lupus nephritis.
2. Lusduna Nexcue
The FDA approved the Lusduna Nexvue on July 20, 2017. This medication is administered through pre-filled dosing device and is used in the treatment of type 2 diabetes. The Lusduna Nexvue is developed by Merck which is funded by Samsung Bioepis.
With its approval, the Lusduna Nexvue met all the regulatory standards required. However, there is a lawsuit from Sanofi. Sanofi claims that there was patent infringement. Sanofi says that this drug infringes ten patent for their glargine injection.
The approval of Lusduna Nexvue is crucial since it brings the medicine closer to patients. This treatment was given provisional approval and can be used in the United States when it is made available. Although this treatment met all the required regulations, it is subjected to automatic stay due to the patent infringement lawsuit by the Sanofi.
On July 6, 2017, the FDA approved Orencia for treatment of active Psoriatic Arthritis in adults. The Psoriatic Arthritis is a chronic inflammatory disease which affects the musculoskeletal system and the skin. Orencia is available in subcutaneous injection and intravenous formulations. However, Orencia cannot be administered concomitantly with tumor necrosis factor antagonist. It cannot also be administered concomitantly with biological Rheumatoid Arthritis therapy like anakinra. The approval marks the 3rd autoimmune disease indication.
The approval underscores the Orencia’s efficacy in adults with Psoriatic Arthritis. The main aim of immune science research should be to improve clinical understanding of autoimmune disease. Orencia acts as an extra treatment option for PSA. Psoriatic Arthritis causes joint pain, reduced a range of movement and stiffness. This can affect the ability to perform other activities during the day such as tying shoes and getting dressed. In the case of PSA, an immune system starts to attack the skin and healthy joints. Orencia is an additional treatment option for active Psoriatic Arthritis patients.
With this approval, subcutaneous and intravenous forms of Orencia can be used to treat active psoriatic arthritis. This drug work by inhibiting T-cell activation. This drug was approved initially for the treatment of rheumatoid arthritis in adults and Juvenile idiopathic arthritis. This drugs had advance side effects on the trial participants and included nausea, nasopharyngitis, headache, and tract infection. Also, TNF antagonist doesn’t allow concurrent therapy to be conducted. There is an increased risk of infection when concurrent therapy is done in this case.
The FDA approved the Vosevi tablets on July 18, 2017. The vosevi was approved to treat chronic hepatitis C genotype 1-6 without liver disease or mild cirrhosis. This drug is a fixed dose. It is made by combining drugs that were approved earlier: velpatasvir, voxilaprevir, and sofosbuvir. Vosevi is approved for patients who have been treated with sofosbuvir or direct-acting antiviral drugs used for treating hepatitis C virus that inhibit NS5A protein.
The direct acting antiviral drugs stop the virus from multiplying. This usually cures hepatitis C virus. These drugs offer an alternative treatment for those who were not treated with other drugs in the past. The efficacy and safety of Vosevi were evaluated in three clinical trials with 750 adults without mild cirrhosis or cirrhosis. The first trial involved 12 weeks treatment with Vosevi in adults with genotype 1 and had failed the previous treatment with NS5A inhibitor drug. It was compared with placebo.
The second trial involved 12 weeks of treatment with Vosevi, and it was compared with velpatasvir and sofosbuvir treatment. The adults undergoing treatment had genotypes 1, 2 or 3 and had failed previous treatment with sofosbuvir. The results showed that about 97% of the patients and had received Vosevi drugs had been cured of the virus within 12 weeks of treatment. There was no virus detected. Recommendations on treatments using Vosevi are different and depends on prior treatment history and viral genotype. However, all patients need to be tested for HBV before the therapy begins since this drug carries risk of hepatitis B virus reactivation
Vosevi drugs have adverse side effects, and the most common are fatigue, nausea, diarrhea, and headache.
- The FDA approved the subcutaneous formulation of Benlysta for treatment of Systematic Lupus Erythematosus for adult patients receiving standard therapy.
- This approval marked the first self-injection treatment for patients with systematic lupus erythematosus.
- The administration of the formulation takes one hour and can be done in a clinic or hospital setting and is done every four weeks.