GSK has released drug remedies for COPD, malaria, meningitis, cancer, anemia, and lupus. They are partnering with 23andMe to pursue genetic studies and discoveries.
PRESS RELEASES FROM GSK- LAST TWELVE MONTHS
Trelegy Ellipta — Japan- May 29, 2018
- An application has been submitted.
- Trelegy Ellipta is a"once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD"
- Japan currently has no triple therapy like this.
Bexsero- Europe- June 27, 2018
- Infants can now be protected against meningitis in fewer doses with an alternative 2+1 dosing schedule instead of the 3+1 schedule.
- Bexsero is given in two doses, followed by a booster. Two months must pass between the first and second dose.
- They hope the reduced doses will improve compliance.
Krintafel- July 20, 2018
- Krintafel is a malaria cure that was approved by the FDA.
- It is in collaboration with Medicines for Malaria (MMV).
- It is indicated for patients age 16 and over.
- "Krintafel is an 8-aminoquinoline derivative with activity against all stages of the P. vivax life cycle, including hypnozoites".
- It is not approved anywhere else in the world, but submissions to Australia have been made.
Partnership With Adaptimmune for T-Cell Therapy (GSK-794)- July 24, 2018
- This therapy is the first one to show a response with solid tumors.
- "GSK ‘794 is an engineered T-cell therapy, for which a patient’s own cells have been genetically modified to express a T-cell receptor (TCR) recognising with high affinity the tumour-specific antigen, NY-ESO. When the modified cells are re-infused into the patient, they recognize and kill tumour cells that express the NY-ESO antigen".
- "NY-ESO is expressed at various levels across different tumours, and appears to be expressed at high levels in defined sub-types of soft tissue sarcomas, melanoma, multiple myeloma, bladder cancer, non-small cell lung cancer, ovarian cancer and gastro-intestinal cancers".
GSK Signs Agreement with 23andMe- July 25, 2018
- They will be working together to use genetic insights to develop new novel medicines.
- The four-year agreement will focus on discovering new cures using genetics as the "basis of discovery".
Kozenis- Australia- September 21, 2018
Mepolizumab For COPD- September 7, 2018
- GSK did not get approval for Mepolizumab for COPD, as the FDA needs more clinical data that it is an effective add-on treatment to "inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts."
- GSK will work with the FDA to determine next steps.
Trelegy Ellipta - Europe- November9, 2018
Daprodustat in Japan- November 22, 2018
- This is a potential new treatment for "anemia associate with chronic kidney disease".
- GSK has partnered with Kyowa Hakko Kirin.
- "We anticipate making a regulatory submission to the Japanese Ministry of Health, Labour and Welfare in 2019 and if approved, we believe daprodustat would be an important new oral treatment option for Japanese patients with anaemia associated with CK".
- "Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the production of red blood cells and iron metabolism, similar to the physiological effects that occur in the body at high altitude".
GSK & Merk Jointly Develop Bintrafusp Alfa- February 5, 2019
- It is an immunotheraphy for difficult to treat cancers.
- "M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers".
- "This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC)."
Dovato by ViiV- April 8, 2019
- Dovato has been approved as a "once daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults".
- In Gemini trials the drug was studied for 48 weeks with no cases of resistance.
- "Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. Dovato, a two-drug regimen (2DR), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen".
- Several other submissions are planned for 2019. It is under review by the "European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland, and South Africa ".
Benlysta- April 26, 2019
- Benlysta has received US approval for "intravenous use in children with lupus aged five years and above".
- This is the first drug approved for children with "systemic lupus erythematosus (SLE)".
- "The approval extends the current indication in the US for the IV formulation of Benlysta in adults, to patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy".
- "The IV formulation of Benlysta is currently not approved for use in children anywhere else in the world although regulatory submissions are ongoing in other parts of the world."
Cabotegravir and Rilpivirine Combo Drug- by ViiV- April 29, 2019
- ViiV submitted an application to the FDA for the "first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV. If approved, cabotegravir and rilpivirine would be the first-ever long-acting, injectable treatment regimen for adults living with HIV".
- ViiV submitted this drug with Pfizer and Shinogi Limited.
- Injected monthly, it has been proven effective as a viral suppressor in a 48-week study.
Shingrix in China- May 23, 2019
- Shingrix has been approved in China for the "prevention of shingles in adults age 50 and over".
- "Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses".
- China put Shingrix on the list of their urgently needed new medicines and expedited review.
- The vaccine has 90% efficacy in all age groups.
Nucala (mepolizumab) — June 6, 2019
- The FDA has approved two new methods for administering "Nucala, and auto-injector and a pre-filled syringe, that is administered every four weeks".
- It is the "first anti-IL5 biologic to be licensed in the US for home administration".
- It is the first "respiratory biologic to be approved for administration by an auto-injector".
Zejula (niraparib)- June 24, 2019
- Tesaro submitted a new drug application for the treatment of "advanced ovarian, fallopian, or primary peritoneal cancer for patients that have been treated with three or more prior chemotherapy regimens".
- Zejula is an active late line treatment.
- It is an oral, once daily PARB inhibitor.
- It is currently being evaluated in three different trials.
CURRENT GSK PRODUCT PIPELINE (06/26/2019)
Detailed information can be accessed here.
- Phase 3: Zejula, dostarlimab,
- Phase 2: dostarlimab, 2857916- B-cell maturation antigen antibody drug conjugate, 3377794-NY-ESO-1 autologous engineered TCR-T cells (engineered TCR), 3359609- Induced T-cell co-stimulator (ICOS) agonist antibody, molibresib (525762), M7824- Transforming growth factor beta, TSR-022- Anti-T-cell immunoglobulin and mucin domain-3 (TIM-3) antibody
- Phase 1/2: 3174998- OX40 agonist monoclonal antibody,
- Phase 1: 3326595- Protein arginine methyltransferase 5 (PRMT5) inhibitor, 1795091- Toll-like receptor 4 (TLR4) agonist, 2636771- Phosphatidylinositol 3-kinase (PI3K) beta inhibitor, 3368715- Protein arginine methyltransferase 1 (PRMT1) inhibitor, 3145095- RIP1 kinase inhibitor, 35371422- NY-ESO-1-targeting bispecific, TSR-033- Anti-lymphocyte activation gene-3 (LAG-3) antibody
- Submitted: Dectova, dolutegravir + lamivudine,
- Phase 3: dolutegravir + lamivudine, fostemsavir, cabotegravir + rilpivirine,
- Phase 2: cabotegravir, gepotidacin, 32288361- HBV antisense oligonucleotide, 33894041- HBV LICA antisense oligonucleotide, 3640254- HIV maturation inhibitor,
- Phase 1: 3036656- Leucyl t-RNA synthetase inhibitor, 3810109- HIV broadly neutralizing antibody
- Phase 3: Benlysta + Rituxan,
- Phase 2: Benlysta + Rituxan, 3196165-Granulocyte macrophage colonystimulating factor monoclonal antibody, 2982772- Receptor-interacting protein 1 (RIP1) kinase inhibitor, 2330811- Oncostatin M (OSM) monoclonal antibody
- Phase 1: 2831781- Lymphocyte activation gene 3 (LAG3) protein monoclonal antibody, 2983559- Receptor-interacting protein 2 (RIP2) kinase inhibitor, 3358699- BET targeted inhibitor, 3858279-CCL17 inhibitor,
- Complete Response Letter: mepolizumab
- Phase 3: mepolizumab, fluticasone furoate + vilanterol + umeclidinium,
- Phase 2: 2586881- Recombinant human angiotensin converting enzyme 2 (rhACE2), 2862277- Tumour necrosis factor receptor-1 (TNFR1) domain antibody, 3772847- Interleukin 33r (IL33r) monoclonal antibody, 2881078- Selective androgen receptor modulator
- Phase 1: nemiralisib, 2292767- Phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, 3511294- Interleukin 5 (IL5) long-acting monoclonal antibody,
- Approved: Shingrix
- Phase 3: Shingrix, Rotarix, Bexsero, MMR
- Phase 2: COPD, Hepatitis C, Malaria next generation, Malaria prophylaxis (Plasmodium falciparum), Menveo Liquid, Shigella, Tuberculosis, RSV, HIV,
- Phase 1/2: RSV, Flu universal,
- Approved: Krintafel
- Phase 3: daprodustat
- Phase 2: oxytocin (inhaled), linerixibat
- Phase 1: 3439171- Hematopoietic prostaglandin D2 (hPGD2) synthase inhibitor
CURRENT LIST OF NEW PRODUCT DEVELOPMENTS (06/26/2019)
Currently, GSK is seeking input and products in the following categories. They require proof of concept at this stage. The complete list can be viewed at GSK.
- Barrier Forming Products for upper respiratory tract
- Antioxidant/Anti-inflammatory products that combat air pollution
- Digital devices to manage respiratory health
- Digital health platforms for respiratory conditions
- Nasal spray deliveries for allergies
- Next generation nicotine replacement- transdermal
- Long lasting reflux management
- Pain relief
- Lower digestive health solutions
Relevant information for GSK was taken directly from their press releases and website. Please note, there is a high occurrence of quotation marks due to the detailed medical jargon.