It was a wickedly busy week so apologies for the paucity of postings. We are over the half-way mark for the year – if the year were represented by the days of the week, it would be Wednesday. Summer school has started. The mosquito has returned. Fireflies flash hello at dusk. Lucky people are at the beach. Me – not so lucky.
Here is a bit of what transpired on this hump day of the year.
- FDA Approves New Type of Leg Prosthesis – This week the agency announced that it has approved a new prosthesis leg device manufactured in Sweden. Current prosthesis involves the use of a cup-like socket that fits over the residual leg of the patient, however for various reasons, some patients are not able to utilize the socket. The new device Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA) is surgically implanted through two procedures using screws and fixtures to the thigh bone. There is a post-surgical course of physical therapy that lasts several months.
- Approval for NSCLC First Line Therapy – This week FDA gave a thumbs up for use of Iressa (giftinib), a kinase inhibitor, to be used as a first-line therapy for patients with Non-Small Cell Lung Cancer where tumors have specific types of epidermal growth factor receptor (EGFR) gene mutations. The therapy targets the most common type of EGFR mutations and FDA referred to it as an example of a highly targeted therapy for treating lung cancer. While Iressa had been approved for a separate use in 2003 and then withdrawn, this use is distinct from its prior designation and was approved as an orphan product. The company press release can be found here.
- Drug Approval for Two Indications in Mental Health – Otsuka’s Rexulti (brexpiprazole) was approved by FDA this week for two indications – for the treatment of schizophrenia and as an add-on treatment for patients with major depressive disorder (MDD). The drug will have a Boxed Warning and were evaluated in separate clinical trials. The company press release can be found here.
That’s it for me this week folks.